FDA 510(k) dataset · 2021–present

How much light does each LED mask actually deliver — and who proves it?

Every LED face mask the FDA has cleared since 2021, with the irradiance each manufacturer declared in its own filing — placed next to the figure it publishes on its own site, so you can compare them without opening two PDFs.

60
face masks cleared
95%
publish their irradiance
178
modes with a declared figure
0
figures that contradict themselves

What this page is

A plain-language directory of every FDA-cleared LED face mask, so you can see how strong each one’s light is and whether that number can be trusted — without opening a single PDF.

  • “Strength” means irradiance — how much light hits your skin each second. It matters because your dose is strength × time, so a mask that never states it can’t be dosed.
  • A bigger number is not better. The skin’s response is biphasic — too much light can hold back the very effect you want.
  • Every figure links to its source. 57 of 60 masks state their strength in their FDA filing, and we found zero makers whose own numbers contradict each other.

See how long each mask takes to reach a given dose · Our corrections log

Showing 60 of 60 masks. Every strength figure links to the document it comes from.

MaskTreatsLight strengthLight coloursSource of the figureCleared
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
Shenzhen Chuangtong Yigou Technology Co., Ltd.
Wrinkles15 mW/cm²varies—FDA filingK261601 ↗2026-08-07
LED Light Therapy Masks (PE748, PE749, PE756)
Duplex International Trading Limited
Wrinkles70 mW/cm²variesBlue, InfraredFDA filingK261496 ↗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.
Wrinkles55 mW/cm²varies—FDA filingK261851 ↗2026-08-04
5 Wavelength LED Facemask (TN2508)
iSMART Developments, Ltd.
Wrinkles52.1 mW/cm²—FDA filingK260598 ↗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.
Wrinkles33.9 mW/cm²varies—FDA filingK261407 ↗2026-07-15
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
Guangdong Newdermo Biotech Co., Ltd.
Wrinkles40 mW/cm²variesBlue, Red, InfraredFDA filingK261052 ↗2026-06-29
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
Guangdong Newdermo Biotech Co., Ltd.
Wrinkles44 mW/cm²varies—FDA filingK260946 ↗2026-06-18
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
The Beauty Tech Group, Ltd.
Wrinkles7 mW/cm²InfraredFDA filingK260715 ↗2026-06-03
myLEDmask 2 (MJ-144)
Light Tree Ventures Europe B.V.
Wrinkles18 mW/cm²varies—FDA filingK260415 ↗2026-05-12
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
NOOANCE
Wrinkles35 mW/cm²varies—FDA filingK260150 ↗2026-04-22
Ulike Reglow Light Therapy Device (UM10)
Shenzhen Ulike Smart Electronics Co., Ltd.
Wrinkles20.5 mW/cm²—FDA filingK260511 ↗2026-03-16
LED Light Therapy Mask (Models: T2, RLD10)
Shenzhen Desida Technology Co., Ltd.
Wrinkles45 mW/cm²varies—FDA filingK254079 ↗2026-03-16
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
SZ KKS Silicone&Electronic Co., Ltd.
Wrinklesnot published—Not publishedK254007 ↗2026-02-12
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.
Wrinkles35 mW/cm²varies—FDA filingK253712 ↗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.
Wrinkles30.3 mW/cm²varies—FDA filingK253400 ↗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.
Wrinkles25 mW/cm²variesRedFDA filingK253135 ↗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.
Wrinkles23 mW/cm²varies—FDA filingK253054 ↗2025-12-19
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
Shenzhen Goodwind Technology Development Co., Ltd.
Wrinkles65 mW/cm²variesRed, InfraredFDA filingK252983 ↗2025-12-17
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
Guangdong Ace-Tec Co., Ltd.
Wrinklespending—PendingK252994 ↗2025-12-08
LED Beauty Mask (RLBXX)
Atop Lighting Co., Ltd.
Wrinkles25 mW/cm²—FDA filingK252308 ↗2025-11-13
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.
Wrinkles55 mW/cm²varies—FDA filingK252264 ↗2025-10-17
Light Therapy Mask (1019055)
Merchsource, LLC
Wrinkles12.5 mW/cm²varies—FDA filingK252093 ↗2025-10-16
LED Light Therapy Mask (2311, 2344, 2457, 2458)
Dongguan Yanxi Technology Co., Ltd.
Wrinkles31 mW/cm²varies—FDA filingK252189 ↗2025-09-12
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
Shenzhen Fittop Health Technology Co., Ltd.
Wrinkles25 mW/cm²RedFDA filingK251588 ↗2025-08-21
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
Shenzhen Liyoutong Technology Co., Ltd.
Wrinklesnot published—Not publishedK251667 ↗2025-08-07
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
Shenzhen Kaiyan Medical Equipment Co., Ltd. · in stores
Wrinkles30 mW/cm²—FDA filingK250966 ↗2025-06-25
LED Facial Mask
Shenzhen Sunsred Technology Co.,Ltd
Wrinkles81 mW/cm²varies—FDA filingK243978 ↗2025-06-20
LED LIGHT MASK (A093)
Foshan Guangyu Weilai Medical Equipment Co., Ltd.
Wrinkles1.98 mW/cm²—FDA filingK250880 ↗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.
Wrinklesnot published—Not publishedK250830 ↗2025-06-09
KALA Red Light Face Mask (KALA-01)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Wrinkles30 mW/cm²varies—FDA filingK250581 ↗2025-05-30
LED Therapy Mask (MN1, M226)
Shenzhen Borria Technology Co., Ltd.
Wrinkles2.7649999999999997 mW/cm²varies—FDA filingK242385 ↗2025-04-07
LED Light Therapy Mask (RT01)
Ningbo Dechang Electrical Machinery Made Co.,Ltd
Acne28 mW/cm²varies—FDA filingK242068 ↗2025-04-04
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Wrinkles25 mW/cm²variesBlue, Amber, Red, InfraredFDA filingK242593 ↗2025-02-14
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
Shenzhen Eyco Technology Co., Ltd.
Acne10.5 mW/cm²varies—FDA filingK243555 ↗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.
Wrinkles45.5 mW/cm²—FDA filingK243423 ↗2025-01-28
Ulike Reglow Light Therapy Device (UM10)
Shenzhen Ulike Smart Electronics Co., Ltd.
Wrinkles20.5 mW/cm²—FDA filingK243492 ↗2025-01-10
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.
Wrinkles9 mW/cm²varies—FDA filingK243040 ↗2024-12-20
CryoGlow (FW3XXXX)
Sharkninja Operating, LLC · in stores
Wrinkles128 mW/cm²varies—FDA filingK242796 ↗2024-11-27
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Wrinkles30 mW/cm²varies—FDA filingK241933 ↗2024-09-27
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
Shenzhen Idea Light Limited
Wrinkles44 mW/cm²—FDA filingK233114 ↗2024-01-12
Led Mask Platinum Exclusive MD
Stg24 Co., Ltd.
Wrinkles1 mW/cm²varies—FDA filingK232795 ↗2023-12-07
TheraFace Mask
Therabody, Inc.
Wrinkles73 mW/cm²varies—FDA filingK230293 ↗2023-06-09
myLEDmask
Myblend
Wrinkles18.7 mW/cm²—FDA filingK223147 ↗2023-05-14
LED Facial Mask
Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.
Wrinkles53 mW/cm²varies—FDA filingK230351 ↗2023-05-05
Q-Rejuvalight Pro Facewear (Model: P19-0023)
Light Tree Ventures Europe B.V.
Wrinkles70 mW/cm²variesBlue, Red, InfraredFDA filingK230042 ↗2023-04-28
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
Light Tree Ventures Europe B.V.
Wrinkles26 mW/cm²varies—FDA filingK230124 ↗2023-03-15
LED light therapy mask (FM-01, FM-02, FM-03)
Guangdong Newdermo Biotech Co., Ltd.
Wrinkles10.5 mW/cm²varies—FDA filingK223544 ↗2023-02-23
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
Light Tree Ventures Europe B.V.
Wrinkles44 mW/cm²varies—FDA filingK221775 ↗2022-12-20
LED Light Therapy Mask (model: MK66R-B)
Light Tree Ventures Europe B.V.
Wrinkles30 mW/cm²—FDA filingK221946 ↗2022-11-22
easy Claire
Y & J Bio Co., Ltd.
Wrinkles20 mW/cm²—FDA filingK223278 ↗2022-11-17
Led Mask Platinum Md
Cellreturn Co., Ltd.
Wrinklespending—PendingK222377 ↗2022-11-03
Beauty LED Mask, Model: KFB265
Hunan Guangye Biotechnology Co., Ltd.
Wrinkles25.5 mW/cm²varies—FDA filingK221151 ↗2022-07-19
Skin Care Beauty Mask (Model: MJ-06)
Shenzhen Kaiyan Medical CO , Ltd.
Wrinkles30 mW/cm²—FDA filingK220168 ↗2022-05-17
Project E Beauty LED Light Therapy Mask (Model: PE730)
Duplex International Trading Limited · in stores
Wrinkles1.07 mW/cm²—FDA filingK214101 ↗2022-03-23
Shani Darden LED light therapy mask
Harpar Grace International
Acne28 mW/cm²varies—FDA filingK214103 ↗2022-03-22
easy Claire
Y & J Bio Co., Ltd.
Wrinkles20 mW/cm²—FDA filingK213285 ↗2022-03-03
MZ Skin LightMAX Supercharged LED Mask 2.0
Mz Skin
Acne28 mW/cm²varies—FDA filingK213184 ↗2021-11-23
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.
Wrinkles6.5 mW/cm²—FDA filingK200983 ↗2021-07-14
Aduro Light Beauty Mask
Shenzhen Kaiyan Medical CO , Ltd.
Wrinkles30 mW/cm²—FDA filingK202390 ↗2021-07-14
Omnilux CLEAR
Globalmed Technologies
Acne28 mW/cm²varies—FDA filingK210948 ↗2021-06-24

“Light strength” is irradiance — how much light reaches the skin each second. Every figure comes from the maker’s own 510(k) filing, with the K number recorded. Not published means the figure is not in the document; Pending means the maker does publish it and we have not logged it yet. How we review · Dose calculator

How we verify each figure, and what we do not claim, is in how we review devices.