Light Therapy Device Index
Every skin light-therapy device cleared by the FDA since 2021 — 129 of them. Masks, wands, panels, patches, brushes and body devices, each with the irradiance its manufacturer declared in its own filing. For face masks only, see the LED face mask index.
What is in here
The dose skin receives is irradiance multiplied by time, so without an irradiance figure there is no way to know how much light a device delivers in a session — however many LEDs or however much total power it advertises.
This is the full corpus: every device cleared under the two OTC light-therapy product codes since 2021, whatever its shape. Those codes describe the authorised indication — wrinkles, acne — not the form factor, so a hair brush, a treatment couch and a face mask can all sit under the same code. 115 of 129 declare an irradiance figure in their filing.
If you are comparing face masks, the face mask index is the one you want: this page is here so that classifying by shape does not throw away the rest of the corpus.
A higher number is not automatically better: the photobiomodulation response is biphasic, and large doses can inhibit rather than stimulate. Across all 129 filings we read, we found no case where a manufacturer’s own published figures contradict each other. The two errors we did find were ours, and they are listed in our corrections log. See how long each device takes to reach a given dose.
129 devices · 14 with no irradiance published by the manufacturer · 8 published but pending extraction
| Device | IrradianceFDA filing | Irradiancemanufacturer site | Wavelengths | Data status | Cleared |
|---|---|---|---|---|---|
Eye Recovery Pro (PH-e03) Shenzhen Goodwind Technology Development Co., Ltd. Eye mask | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK261602 | 2026-08-10 |
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Shenzhen Chuangtong Yigou Technology Co., Ltd. Face mask | nir: 9–12 mW/cm² · red+nir: 8–22 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K261601 | 2026-08-07 |
LED Light Therapy Masks (PE748, PE749, PE756) Duplex International Trading Limited Face mask | 880nm: 70 mW/cm² · 415nm: 45 mW/cm² 2 modes | not checked | 415, 880 nmNIR | ✅ FDA 510(k)K261496 | 2026-08-04 |
LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) Shenzhen Qianyu Technology Co., Ltd. Face mask | red: 10 mW/cm² · blue: 15 mW/cm² · red: 15 mW/cm² 10 modes | not checked | — | ✅ FDA 510(k)K261851 | 2026-08-04 |
LightStim for Wrinkles (1984); LightStim for Acne (2038) Led Intellectual Properties, LLC Wand / handheld | 21.6 mW/cm² | not checked | — | ✅ FDA 510(k)K261482 | 2026-07-31 |
5 Wavelength LED Facemask (TN2508) iSMART Developments, Ltd. Face mask | 52.1 mW/cm² | not checked | — | ✅ FDA 510(k)K260598 | 2026-07-24 |
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) Dongguan Miqiang Technology Co., Ltd. Face mask | red: 14.43 mW/cm² · blue: 33.9 mW/cm² · yellow: 2.55 mW/cm² 5 modes | not checked | — | ✅ FDA 510(k)K261407 | 2026-07-15 |
Chromix Termosalud S.L. Unclassified | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK261473 | 2026-07-01 |
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) Guangdong Newdermo Biotech Co., Ltd. Face mask + Neck / chest | 630nm: 21 mW/cm² · 415nm: 19 mW/cm² · 605nm: 15 mW/cm² 6 modes | not checked | 415, 605, 630, 830 nmNIR | ✅ FDA 510(k)K261052 | 2026-06-29 |
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) Guangdong Newdermo Biotech Co., Ltd. Face mask | nir: 40 mW/cm² · blue: 19 mW/cm² · amber: 15 mW/cm² 5 modes | not checked | — | ✅ FDA 510(k)K260946 | 2026-06-18 |
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) Shenzhen Kaiyan Medical Equipment Co., Ltd. Neck / chest | 465nm: 8–12 mW/cm² · 630nm: 8–12 mW/cm² · 830nm: 10–14 mW/cm² 4 modes | not checked | 465, 590, 630, 830 nmNIR | ✅ FDA 510(k)K254025 | 2026-06-16 |
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) The Beauty Tech Group, Ltd. Face mask | 1072nm: 7 mW/cm² | not checked | 1072 nmNIR | ✅ FDA 510(k)K260715 | 2026-06-03 |
myLEDmask 2 (MJ-144) Light Tree Ventures Europe B.V. Face mask | total: 12–24 mW/cm² · red: 8–16 mW/cm² · nir: 4–8 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K260415 | 2026-05-12 |
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) NOOANCE Face mask | red: 30 mW/cm² · nir: 15 mW/cm² · red: 15 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K260150 | 2026-04-22 |
LED Light Therapy Masks (LumiLips FAC07NA) Guangdong Newdermo Biotech Co., Ltd. Unclassified | 880nm: 40 mW/cm² | not checked | 880 nmNIR | ✅ FDA 510(k)K260202 | 2026-03-23 |
Ulike Reglow Light Therapy Device (UM10) Shenzhen Ulike Smart Electronics Co., Ltd. Face mask | 1–40 mW/cm² | not checked | — | ✅ FDA 510(k)K260511 | 2026-03-16 |
LED Light Therapy Mask (Models: T2, RLD10) Shenzhen Desida Technology Co., Ltd. Face mask | red+nir: 30–45 mW/cm² · blue: 40–50 mW/cm² · mixedlight: 40–50 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K254079 | 2026-03-16 |
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) Shenzhen Kaiyan Medical Equipment Co., Ltd. Patch | red: 5–8 mW/cm² · blue: 23–27 mW/cm² · total: 28–35 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K253878 | 2026-03-04 |
LED Therapy Light (COB1400, HP1800PRO) Shenzhen Hanhua Opto Co., Ltd. Panel | red: 6.147 mW/cm² · nir: 1.425 mW/cm² · nir: 7.687 mW/cm² 6 modes | not checked | — | ✅ FDA 510(k)K253874 | 2026-03-03 |
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) SZ KKS Silicone&Electronic Co., Ltd. Face mask | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK254007 | 2026-02-12 |
Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) Shenzhen Jianchao Intelligent Technology Co., Ltd. Body | blue: 4.48 mW/cm² · red: 2.3 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K253833 | 2026-01-30 |
HIGHERDOSE Body Sculptor (Model: GS-03) Shenzhen Kaiyan Medical Equipment Co., Ltd. Body | total: 40 mW/cm² | not checked | — | ✅ FDA 510(k)K252603 | 2026-01-28 |
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) Shenzhen Rainbow Technology Co., Ltd. Face mask | red: 20 mW/cm² · nir: 4 mW/cm² · blue: 35 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K253712 | 2026-01-23 |
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) Shenzhen Saidi Light Therapy Technology Co., Ltd. Face mask | nir: 30.3 mW/cm² · blue: 30 mW/cm² · amber: 29.6 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K253400 | 2025-12-24 |
Feather/numiere 05 06 07 (05) Heat IN A Click, LLC Unclassified | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK253279 | 2025-12-24 |
LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) Dongguan Yijiaming Technology Co., Ltd. Face mask | 605nm: 15 mW/cm² · 630nm: 20 mW/cm² · 660nm: 25 mW/cm² 3 modes | not checked | 605, 630, 660 nm | ✅ FDA 510(k)K253135 | 2025-12-23 |
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Face mask | mode1: 13–33 mW/cm² · mode3: 5–13 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K253054 | 2025-12-19 |
LED Light Therapy Device (Models: SG-FM, SG-FE) Sunglor Technology Co., Ltd. Unclassified | 850nm: 3 mW/cm² · 630nm: 22 mW/cm² · 605nm: 14 mW/cm² 4 modes | not checked | 460, 605, 630, 850 nmNIR | ✅ FDA 510(k)K253086 | 2025-12-19 |
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) Shenzhen Goodwind Technology Development Co., Ltd. Face mask | 605nm: 25 mW/cm² · 630nm: 14 mW/cm² · 660nm: 18 mW/cm² 5 modes | not checked | 605, 630, 660, 830 nmNIR | ✅ FDA 510(k)K252983 | 2025-12-17 |
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) Guangdong Ace-Tec Co., Ltd. Face mask | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK252994 | 2025-12-08 |
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) Shenzhen Siken 3D Technology Development Co., Ltd. Wand / handheld | red: 2.3 mW/cm² · blue: 1.33 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K252142 | 2025-12-05 |
Microcurrent Facial Device (CEC101, EEI101) Shenzhen Dachi Communication Co., Ltd. Microcurrent | blue: 0.75 mW/cm² · red: 0.77 mW/cm² · blue: 1.12 mW/cm² 5 modes | not checked | — | ✅ FDA 510(k)K252642 | 2025-11-19 |
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) Sunglor Technology Co., Ltd. Unclassified | 830nm: 3 mW/cm² · 630nm: 22 mW/cm² · 605nm: 14 mW/cm² 3 modes | not checked | 605, 630, 830 nmNIR | ✅ FDA 510(k)K253073 | 2025-11-19 |
LED Beauty Mask (RLBXX) Atop Lighting Co., Ltd. Face mask | total: 25 mW/cm² | not checked | — | ✅ FDA 510(k)K252308 | 2025-11-13 |
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd Brush | 3 mW/cm² | not checked | — | ✅ FDA 510(k)K252053 | 2025-10-27 |
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) Shenzhen Zhenxing Ruitong Technology Co., Ltd. Face mask | red: 10 mW/cm² · blue: 15 mW/cm² · red: 15 mW/cm² 10 modes | not checked | — | ✅ FDA 510(k)K252264 | 2025-10-17 |
Light Therapy Mask (1019055) Merchsource, LLC Face mask | red: 5–20 mW/cm² · blue: 5–20 mW/cm² · red+nir: 5–20 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K252093 | 2025-10-16 |
ORA Method LED Gua Sha (GS-04) Shenzhen Kaiyan Medical Equipment Co., Ltd. Wand / handheld | total: 20–35 mW/cm² | not checked | — | ✅ FDA 510(k)K252272 | 2025-10-09 |
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) Shenzhen Ulike Smart Electronics Co., Ltd. Unclassified | blue: 11.2 mW/cm² · red: 8.2 mW/cm² · nir: 7 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K251825 | 2025-10-01 |
Light Therapy Decollete Mask (1019135) Merchsource, LLC Neck / chest | 30 mW/cm² | not checked | — | ✅ FDA 510(k)K252096 | 2025-10-01 |
LED Light Therapy Mask (2311, 2344, 2457, 2458) Dongguan Yanxi Technology Co., Ltd. Face mask | red+nir: 15–22 mW/cm² · blue: 16–29 mW/cm² · amber: 6–10 mW/cm² 14 modes | not checked | — | ✅ FDA 510(k)K252189 | 2025-09-12 |
Erchonia EVRL Erchonia Corporation Laser | red: 15 mW/cm² | not checked | — | ✅ FDA 510(k)K251843 | 2025-09-12 |
KALA MINI 2.0 (KALA-04) Shenzhen Kaiyan Medical Equipment Co., Ltd. Panel | 660nm: 50 mW/cm² · 850nm: 50 mW/cm² · total: 100 mW/cm² 3 modes | not checked | 660, 850 nmNIR | ✅ FDA 510(k)K251781 | 2025-09-04 |
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) Shenzhen Fittop Health Technology Co., Ltd. Face mask | 630nm: 25 mW/cm² | not checked | 630 nm | ✅ FDA 510(k)K251588 | 2025-08-21 |
FEATHER 01 02 03 04 (Model:01) Heat IN A Click, LLC Unclassified | 70 mW/cm² | not checked | — | ✅ FDA 510(k)K251871 | 2025-08-15 |
TRUDERMAL Pro (ZLD-390) Shenzhen Kaiyan Medical Equipment Co., Ltd. Unclassified | blue: 6–10 mW/cm² · red: 10–15 mW/cm² · nir: 6–10 mW/cm² 5 modes | not checked | — | ✅ FDA 510(k)K251012 | 2025-08-14 |
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) Shenzhen Liyoutong Technology Co., Ltd. Face mask | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK251667 | 2025-08-07 |
KALA Therapy Wand (Model: KALA-03) Shenzhen Kaiyan Medical Equipment Co., Ltd. Wand / handheld | red: 20 mW/cm² · blue: 15 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K250761 | 2025-07-11 |
CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) Shenzhen Kaiyan Medical Equipment Co., Ltd. Face maskSold as CurrentBody Skin LED Light Therapy Mask Series 2 | 30 mW/cm² | 30 mW/cm² | — | ✅ FDA 510(k)K250966 | 2025-06-25 |
LED Facial Mask Shenzhen Sunsred Technology Co.,Ltd Face mask | red: 36 mW/cm² · red: 19 mW/cm² · blue: 6.1 mW/cm² 6 modes | not checked | — | ✅ FDA 510(k)K243978 | 2025-06-20 |
LED LIGHT MASK (A093) Foshan Guangyu Weilai Medical Equipment Co., Ltd. Face mask | red: 1.98 mW/cm² | not checked | — | ✅ FDA 510(k)K250880 | 2025-06-20 |
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) Shenzhen Sungrow Led Technology Co., Ltd. Face mask | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK250830 | 2025-06-09 |
Light Therapy System (M500, L6) Guangzhou Ahead Intelligent Technology Co., Ltd. Unclassified | blue: 40 mW/cm² · amber: 10 mW/cm² · red+nir: 20 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K251042 | 2025-06-06 |
KALA Red Light Face Mask (KALA-01) Shenzhen Kaiyan Medical Equipment Co., Ltd. Face mask | red: 20 mW/cm² · nir: 10 mW/cm² · total: 30 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K250581 | 2025-05-30 |
Solawave 2-in-1 Skincare Mini (Model: 61043) Shenzhen Kaiyan Medical Equipment Co., Ltd. Wand / handheld | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK250532 | 2025-05-22 |
Wrinkle Treatment Device (JM1, JM2B) Shenzhen Qianyu Technology Co., Ltd. Unclassified | 90 / 100 mW/cm² | not checked | — | ✅ FDA 510(k)K244020 | 2025-05-01 |
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) Shenzhen Nuon Medical Equipment Co., Ltd. Wand / handheld | 630±10nm: 20–50 mW/cm² · 830±10nm: 25–55 mW/cm² · total: 45–105 mW/cm² 6 modes | not checked | 415, 590, 630, 830 nmNIR | ✅ FDA 510(k)K242151 | 2025-04-08 |
LED Therapy Mask (MN1, M226) Shenzhen Borria Technology Co., Ltd. Face mask | red: 0.89–2.55 mW/cm² · blue: 1.44–4.09 mW/cm² · nir: 1.83–3.05 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K242385 | 2025-04-07 |
LED Light Therapy Mask (RT01) Ningbo Dechang Electrical Machinery Made Co.,Ltd Face mask | blue: 28 mW/cm² · red: 16 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K242068 | 2025-04-04 |
LMNT O2 Xplr , Ltd. Unclassified | 69 mW/cm² · 633nm: 53 mW/cm² · 830nm: 49 mW/cm² 3 modes | not checked | 633, 830 nmNIR | ✅ FDA 510(k)K250125 | 2025-03-24 |
EnergyLounger (TY-01) Shenzhen Kaiyan Medical Equipment Co., Ltd. Body | m1 630nm: 4.2 mW/cm² · m2 630nm+850nm: 18.7 mW/cm² · m3 630+850+940nm: 60 mW/cm² 3 modes | not checked | 630, 850, 940 nmNIR | ✅ FDA 510(k)K241947 | 2025-03-03 |
LYMA Laser PRO Lyma Life , Ltd. Laser | 71 mW/cm² | not checked | — | ✅ FDA 510(k)K243330 | 2025-02-21 |
CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) Shenzhen Kaiyan Medical Equipment Co., Ltd. Face mask | 415nm: 25 mW/cm² · 633nm: 20 mW/cm² · 590nm: 15 mW/cm² 4 modes | not checked | 415, 590, 633, 830 nmNIR | ✅ FDA 510(k)K242593 | 2025-02-14 |
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) Shenzhen Eyco Technology Co., Ltd. Face mask | nir: 6–8 mW/cm² · blue: 2–4 mW/cm² · mixed: 9–12 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K243555 | 2025-02-05 |
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) Shenzhen Rainbow Technology Co., Ltd. Face mask | 45.5 mW/cm² | not checked | — | ✅ FDA 510(k)K243423 | 2025-01-28 |
Ulike Reglow Light Therapy Device (UM10) Shenzhen Ulike Smart Electronics Co., Ltd. Face mask | 1–40 mW/cm² | not checked | — | ✅ FDA 510(k)K243492 | 2025-01-10 |
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) Dongguan Laiguang Electronic Technology Co., Ltd. Panel | 7.5 mW/cm² | not checked | — | ✅ FDA 510(k)K242789 | 2025-01-02 |
LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) Shenzhen Siken 3D Technology Development Co., Ltd. Face mask | red: 5.5 mW/cm² · blue: 9 mW/cm² · red: 5 mW/cm² 10 modes | not checked | — | ✅ FDA 510(k)K243040 | 2024-12-20 |
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) Shenzhen Nuon Medical Equipment Co., Ltd. Eye mask | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK242700 | 2024-12-19 |
LED Light Therapy Machine (G1, G3, G4, G6) Shenzhen Walton Technology Co., Ltd. Unclassified | red: 2–3 mW/cm² · blue: 2–4 mW/cm² · nir: 2–4 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K242638 | 2024-11-27 |
CryoGlow (FW3XXXX) Sharkninja Operating, LLC Face maskSold as Shark Beauty CryoGlow LED Face Mask | blue: 59.8 mW/cm² · red: 17 mW/cm² · nir: 51.2 mW/cm² 10 modes | not checked | — | ✅ FDA 510(k)K242796 | 2024-11-27 |
décoLITE LED Device iSMART Developments, Ltd. Unclassified | total: 30 mW/cm² | not checked | — | ✅ FDA 510(k)K242382 | 2024-11-08 |
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Shenzhen Aozemei Technology Co., Ltd. Microcurrent | red: 2.5 mW/cm² · amber: 15 mW/cm² · blue: 1.4 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K241718 | 2024-10-28 |
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) Dongguan Boyuan Intelligent Technology Co.,Ltd Unclassified | red: 25 mW/cm² · nir: 3 mW/cm² · red+nir: 30 mW/cm² 6 modes | not checked | — | ✅ FDA 510(k)K241857 | 2024-10-11 |
HIGHERDOSE Red and Infrared Light Mask (MK66-L) Shenzhen Kaiyan Medical Equipment Co., Ltd. Face mask | red: 20 mW/cm² · infraredred: 30 mW/cm² 2 modes | 50 mW/cm² total (630nm: 26, 830nm: 24) | — | ✅ FDA 510(k)K241933 | 2024-09-27 |
Luna 4 plus Foreo, Inc. Brush | red+nir: 63 mW/cm² | not checked | — | ✅ FDA 510(k)K241102 | 2024-08-20 |
PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) Dongguan Hunter Electronic Technology Co., Ltd. Wand / handheld | red: 70 mW/cm² | not checked | — | ✅ FDA 510(k)K241203 | 2024-07-25 |
Face Patches (MT-12MA, MT-12MC) Shenzhen Kaiyan Medical Equipment Co., Ltd. Patch | 630nm: 5 mW/cm² · 415nm: 25 mW/cm² · 630+415nm: 30 mW/cm² 8 modes | not checked | 415, 590, 630, 830 nmNIR | ✅ FDA 510(k)K240089 | 2024-04-10 |
Wrinkle Treatment Device (JM2) Shenzhen Qianyu Technology Co., Ltd. Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK240360 | 2024-04-05 |
NUNA LUX (NUNL528) Premier North America, Inc. Unclassified | 62.5 mW/cm² | not checked | — | ✅ FDA 510(k)K233862 | 2024-03-01 |
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) Shenzhen Idea Light Limited Face mask | red: 44 mW/cm² | not checked | — | ✅ FDA 510(k)K233114 | 2024-01-12 |
LED Eye mask (EY-20R, A20, EY-20N) Shenzhen Kaiyan Medical Equipment Co., Ltd. Eye mask | 605nm: 26.2 mW/cm² | not checked | 605 nm | ✅ FDA 510(k)K233556 | 2024-01-04 |
Radiant Renewal Skincare Wand (HD-15, HD-15A) Shenzhen Kaiyan Medical Equipment Co., Ltd. Wand / handheld | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK232863 | 2023-12-13 |
Led Mask Platinum Exclusive MD Stg24 Co., Ltd. Face mask | red: 1 mW/cm² · nir: 1 mW/cm² · blue: 1 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K232795 | 2023-12-07 |
BLU TOTALE (Model: ENEOB852) Premier North America, Inc. Unclassified | 50 mW/cm² | not checked | — | ✅ FDA 510(k)K232656 | 2023-11-14 |
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT Dongguan Hunter Electronic Technology Co., Ltd. Unclassified | blue: 70 mW/cm² | not checked | — | ✅ FDA 510(k)K230490 | 2023-10-27 |
B.Light Clear Evo and B.Light Restore Evo Bemer Int AG Unclassified | red: 0.76 mW/cm² · blue: 1.2 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K223919 | 2023-09-23 |
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) iSMART Developments, Ltd. Patch | 44 mW/cm² | not checked | — | ✅ FDA 510(k)K231555 | 2023-07-27 |
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 Light Tree Ventures Europe B.V. Patch | red: 5 mW/cm² · blue: 25 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K230720 | 2023-07-03 |
TheraFace Mask Therabody, Inc. Face mask | red: 73 mW/cm² · blue: 64 mW/cm² · red+nir: 73 mW/cm² 3 modes | 55 mW/cm² (Mask), 87 mW/cm² (Mask Glo) | — | ✅ FDA 510(k)K230293 | 2023-06-09 |
Infrared Heat (Model: E0221) Light Tree Ventures Europe B.V. Unclassified | 630nm+830nm: 30 mW/cm² | not checked | 630, 830 nmNIR | ✅ FDA 510(k)K223893 | 2023-05-16 |
myLEDmask Myblend Face mask | 18.7 mW/cm² | not checked | — | ✅ FDA 510(k)K223147 | 2023-05-14 |
LED Facial Mask Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. Face mask | blue: 15–63 mW/cm² · red: 31–75 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K230351 | 2023-05-05 |
Q-Rejuvalight Pro Facewear (Model: P19-0023) Light Tree Ventures Europe B.V. Face mask | 605nm: 15 mW/cm² · 630nm: 20 mW/cm² · 660nm: 25 mW/cm² 6 modes | not checked | 415, 605, 630, 660, 880 nmNIR | ✅ FDA 510(k)K230042 | 2023-04-28 |
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) Light Tree Ventures Europe B.V. Face mask | blue: 26 mW/cm² · red: 16 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K230124 | 2023-03-15 |
LED light therapy mask (FM-01, FM-02, FM-03) Guangdong Newdermo Biotech Co., Ltd. Face mask | red: 2–3 mW/cm² · blue: 2–4 mW/cm² · nir: 2–4 mW/cm² 4 modes | not checked | — | ✅ FDA 510(k)K223544 | 2023-02-23 |
NIRA Model 2 Dermal Photonics Corp Laser | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK222685 | 2023-02-08 |
reVive Light Therapy® Wrinkle and Acne LED Device Led Technologies, Inc. Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK223482 | 2022-12-21 |
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) Light Tree Ventures Europe B.V. Face mask | 20–30 mW/cm² · red: 44 mW/cm² · nir: 30 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K221775 | 2022-12-20 |
LED Eye Perfector, model: EY-36A, EY-36B Light Tree Ventures Europe B.V. Eye mask | 65 mW/cm² | not checked | — | ✅ FDA 510(k)K221444 | 2022-12-08 |
LED Light Therapy Mask (model: MK66R-B) Light Tree Ventures Europe B.V. Face mask | 30 mW/cm² | not checked | — | ✅ FDA 510(k)K221946 | 2022-11-22 |
easy Claire Y & J Bio Co., Ltd. Face mask | total: 20 mW/cm² | not checked | — | ✅ FDA 510(k)K223278 | 2022-11-17 |
Led Mask Platinum Md Cellreturn Co., Ltd. Face mask | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK222377 | 2022-11-03 |
reVive Light Therapy LED Cleansing System Led Technologies, Inc. Brush | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK221430 | 2022-07-27 |
Synergy Marble (Model: Opasm) Yrs Group, Inc. Wand / handheld | red: 55.3 mW/cm² | not checked | — | ✅ FDA 510(k)K220064 | 2022-07-22 |
Beauty LED Mask, Model: KFB265 Hunan Guangye Biotechnology Co., Ltd. Face mask | red+nir: 25.5 mW/cm² · blue: 1.36 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K221151 | 2022-07-19 |
The Luminance RED Acne Device Luminance Medical Ventures, Inc. Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK220729 | 2022-06-09 |
Micro-current facial cold and hot service (model: TPML-100) Li-Tek Electronics Technology C0., Ltd. Microcurrent | blue: 25 mW/cm² · red: 45 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K213039 | 2022-05-25 |
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine Marci Beauty, Inc. Unclassified | blue: 5.4 mW/cm² · red: 7.2 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K210545 | 2022-05-20 |
Skin Care Beauty Mask (Model: MJ-06) Shenzhen Kaiyan Medical CO , Ltd. Face mask | 30 mW/cm² | not checked | — | ✅ FDA 510(k)K220168 | 2022-05-17 |
Trinity Plus Wrinkle Reducer Carol Cole Company Dba Nuface Microcurrent | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK212947 | 2022-04-02 |
Project E Beauty LED Light Therapy Mask (Model: PE730) Duplex International Trading Limited Face maskSold as Project E Beauty LumaLux Face+ | mode1: 1.07 mW/cm² | not checked | — | ✅ FDA 510(k)K214101 | 2022-03-23 |
Shani Darden LED light therapy mask Harpar Grace International Face mask | blue: 28 mW/cm² · red: 16 mW/cm² 2 modes | 29–44 mW/cm² | — | ✅ FDA 510(k)K214103 | 2022-03-22 |
LYMA Laser Lyma Life , Ltd. Laser | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK210823 | 2022-03-18 |
easy Claire Y & J Bio Co., Ltd. Face mask | total: 20 mW/cm² | not checked | — | ✅ FDA 510(k)K213285 | 2022-03-03 |
LightStim Elipsa Led Intellectual Properties, LLC Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK212771 | 2022-01-26 |
ENEO TOTALE (Model: ENEOT947) Premier North America, Inc. Unclassified | 69 mW/cm² · 633nm: 56 mW/cm² 2 modes | not checked | 633 nm | ✅ FDA 510(k)K213841 | 2022-01-06 |
Oren LED Perioral Light Therapy System Shenzhen Kaiyan Medical CO , Ltd. Unclassified | 67.7 mW/cm² | not checked | — | ✅ FDA 510(k)K213024 | 2021-12-22 |
TheraFace LED Theragun, Inc. Unclassified | red: 73 mW/cm² · blue: 64 mW/cm² · red+nir: 55 mW/cm² 3 modes | not checked | — | ✅ FDA 510(k)K212155 | 2021-12-21 |
reVive Light Therapy Essentials Led Technologies, Inc. Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK210968 | 2021-12-21 |
reVive Light Therapy Essentials Led Technologies, Inc. Unclassified | Manufacturer does not publish it | not checked | — | ❌ Manufacturer does not publish itK210965 | 2021-12-15 |
MZ Skin LightMAX Supercharged LED Mask 2.0 Mz Skin Face mask | blue: 28 mW/cm² · red: 16 mW/cm² 2 modes | 30 mW/cm² (anti-ageing mode), 18 J/cm² | — | ✅ FDA 510(k)K213184 | 2021-11-23 |
Dermalux Flex MD Aesthetic Technology, Ltd. Panel | 633nm: 11.5 mW/cm² · 415nm: 5.52 mW/cm² · 830nm: 5.5 mW/cm² 3 modes | not checked | 415, 633, 830 nmNIR | ✅ FDA 510(k)K212275 | 2021-11-18 |
DemarkQ WOW, DemarkQ POP Shenzhen Kaiyan Medical CO , Ltd. Panel | red: 5 mW/cm² · blue: 25 mW/cm² 2 modes | not checked | — | ✅ FDA 510(k)K203214 | 2021-07-22 |
Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine Ningbo Hesi Electric Co., Ltd. Face mask | 6.5 mW/cm² | not checked | — | ✅ FDA 510(k)K200983 | 2021-07-14 |
Aduro Light Beauty Mask Shenzhen Kaiyan Medical CO , Ltd. Face mask | 30 mW/cm² | not checked | — | ✅ FDA 510(k)K202390 | 2021-07-14 |
Synergy Yrs Group, Inc. Unclassified | 65 mW/cm² | not checked | — | ✅ FDA 510(k)K210954 | 2021-06-29 |
Omnilux CLEAR Globalmed Technologies Face mask | blue: 28 mW/cm² · red: 16 mW/cm² 2 modes | 44 mW/cm² total | — | ✅ FDA 510(k)K210948 | 2021-06-24 |
Looper (Model: ZX-579S) Heat IN A Click, LLC Wand / handheld | Published, extraction pending | not checked | — | 🔍 Published, extraction pendingK202055 | 2021-04-16 |
Every technical figure comes from the manufacturer’s own 510(k) filing, with the K number and page recorded. “Manufacturer does not publish it” means we looked for the figure in the document and it is not there. “Extraction pending” is the opposite: the manufacturer does publish it and our extraction has not read it yet, so the limitation is ours. How we review · Dose calculator
How we verify each figure, and what we do not claim, is in how we review devices.