Atlas FDA

OHS

161 FDA 510(k) clearances · Product code

90 daysmedian time to decision
255 days90th percentile
161clearances measured

FDA profile

Official device name
Light Based Over The Counter Wrinkle Reduction
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
FDA definition
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Adverse events (MAUDE)
2025: 37 · 2026: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (K261601)Shenzhen Chuangtong Yigou Technology Co., Ltd.2026-08-07
LED Light Therapy Masks (PE748, PE749, PE756) (K261496)Duplex International Trading Limited2026-08-04
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) (K261851)Shenzhen Qianyu Technology Co., Ltd.2026-08-04
LightStim for Wrinkles (1984); LightStim for Acne (2038) (K261482)Led Intellectual Properties, LLC2026-07-31
5 Wavelength LED Facemask (TN2508) (K260598)iSMART Developments, Ltd.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) (K261407)Dongguan Miqiang Technology Co., Ltd.2026-07-15
Chromix (K261473)Termosalud S.L.2026-07-01
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (K261052)Guangdong Newdermo Biotech Co., Ltd.2026-06-29
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (K260946)Guangdong Newdermo Biotech Co., Ltd.2026-06-18
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (K254025)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-06-16
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (K260715)The Beauty Tech Group, Ltd.2026-06-03
myLEDmask 2 (MJ-144) (K260415)Light Tree Ventures Europe B.V.2026-05-12
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (K260150)NOOANCE2026-04-22
LED Light Therapy Masks (LumiLips FAC07NA) (K260202)Guangdong Newdermo Biotech Co., Ltd.2026-03-23
Ulike Reglow Light Therapy Device (UM10) (K260511)Shenzhen Ulike Smart Electronics Co., Ltd.2026-03-16
LED Light Therapy Mask (Models: T2, RLD10) (K254079)Shenzhen Desida Technology Co., Ltd.2026-03-16
LED Therapy Light (COB1400, HP1800PRO) (K253874)Shenzhen Hanhua Opto Co., Ltd.2026-03-03
FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (K253683)Foreo, Inc.2026-02-20
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (K254007)SZ KKS Silicone&Electronic Co., Ltd.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) (K253833)Shenzhen Jianchao Intelligent Technology Co., Ltd.2026-01-30
HIGHERDOSE Body Sculptor (Model: GS-03) (K252603)Shenzhen Kaiyan Medical Equipment Co., Ltd.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) (K253712)Shenzhen Rainbow Technology Co., Ltd.2026-01-23
Feather/numiere 05 06 07 (05) (K253279)Heat IN A Click, LLC2025-12-24
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) (K253400)Shenzhen Saidi Light Therapy Technology Co., Ltd.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.) (K253135)Dongguan Yijiaming Technology Co., Ltd.2025-12-23
LED Light Therapy Device (Models: SG-FM, SG-FE) (K253086)Sunglor Technology Co., Ltd.2025-12-19
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (K253054)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.2025-12-19
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) (K252983)Shenzhen Goodwind Technology Development Co., Ltd.2025-12-17
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (K252994)Guangdong Ace-Tec Co., Ltd.2025-12-08
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252142)Shenzhen Siken 3D Technology Development Co., Ltd.2025-12-05
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (K253073)Sunglor Technology Co., Ltd.2025-11-19
Microcurrent Facial Device (CEC101, EEI101) (K252642)Shenzhen Dachi Communication Co., Ltd.2025-11-19
LED Beauty Mask (RLBXX) (K252308)Atop Lighting Co., Ltd.2025-11-13
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (K252053)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd2025-10-27
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) (K252264)Shenzhen Zhenxing Ruitong Technology Co., Ltd.2025-10-17
Light Therapy Mask (1019055) (K252093)Merchsource, LLC2025-10-16
ORA Method LED Gua Sha (GS-04) (K252272)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-10-09
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (K251825)Shenzhen Ulike Smart Electronics Co., Ltd.2025-10-01
Light Therapy Decollete Mask (1019135) (K252096)Merchsource, LLC2025-10-01
LED Light Therapy Mask (2311, 2344, 2457, 2458) (K252189)Dongguan Yanxi Technology Co., Ltd.2025-09-12
KALA MINI 2.0 (KALA-04) (K251781)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-09-04
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588)Shenzhen Fittop Health Technology Co., Ltd.2025-08-21
FEATHER 01 02 03 04 (Model:01) (K251871)Heat IN A Click, LLC2025-08-15
TRUDERMAL Pro (ZLD-390) (K251012)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-08-14
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) (K251667)Shenzhen Liyoutong Technology Co., Ltd.2025-08-07
KALA Therapy Wand (Model: KALA-03) (K250761)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-07-11
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (K250966)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-06-25
LED Facial Mask (K243978)Shenzhen Sunsred Technology Co.,Ltd2025-06-20
LED LIGHT MASK (A093) (K250880)Foshan Guangyu Weilai Medical Equipment Co., Ltd.2025-06-20
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (K250830)Shenzhen Sungrow Led Technology Co., Ltd.2025-06-09
Light Therapy System (M500, L6) (K251042)Guangzhou Ahead Intelligent Technology Co., Ltd.2025-06-06
KALA Red Light Face Mask (KALA-01) (K250581)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-05-30
Solawave 2-in-1 Skincare Mini (Model: 61043) (K250532)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-05-22
Wrinkle Treatment Device (JM1, JM2B) (K244020)Shenzhen Qianyu Technology Co., Ltd.2025-05-01
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (K242151)Shenzhen Nuon Medical Equipment Co., Ltd.2025-04-08
LED Therapy Mask (MN1, M226) (K242385)Shenzhen Borria Technology Co., Ltd.2025-04-07
LMNT O2 (K250125)Xplr , Ltd.2025-03-24
Aglaia LED Beauty Device (BP-D2309) (K250413)Shenzhen Perfect Idea Technology Limited2025-03-18
EnergyLounger (TY-01) (K241947)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-03-03
LYMA Laser PRO (K243330)Lyma Life , Ltd.2025-02-21
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (K242593)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-02-14
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (K243423)Shenzhen Rainbow Technology Co., Ltd.2025-01-28
Ulike Reglow Light Therapy Device (UM10) (K243492)Shenzhen Ulike Smart Electronics Co., Ltd.2025-01-10
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) (K242789)Dongguan Laiguang Electronic Technology Co., Ltd.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) (K243040)Shenzhen Siken 3D Technology Development Co., Ltd.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) (K242700)Shenzhen Nuon Medical Equipment Co., Ltd.2024-12-19
LED Light Therapy Machine (G1, G3, G4, G6) (K242638)Shenzhen Walton Technology Co., Ltd.2024-11-27
CryoGlow (FW3XXXX) (K242796)Sharkninja Operating, LLC2024-11-27
décoLITE LED Device (K242382)iSMART Developments, Ltd.2024-11-08
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K241718)Shenzhen Aozemei Technology Co., Ltd.2024-10-28
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (K241857)Dongguan Boyuan Intelligent Technology Co.,Ltd2024-10-11
HIGHERDOSE Red and Infrared Light Mask (MK66-L) (K241933)Shenzhen Kaiyan Medical Equipment Co., Ltd.2024-09-27
Luna 4 plus (K241102)Foreo, Inc.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) (K241203)Dongguan Hunter Electronic Technology Co., Ltd.2024-07-25
FAQ™ 201, FAQ™ 202 (K240378)Foreo, Inc.2024-04-19
Face Patches (MT-12MA, MT-12MC) (K240089)Shenzhen Kaiyan Medical Equipment Co., Ltd.2024-04-10
Wrinkle Treatment Device (JM2) (K240360)Shenzhen Qianyu Technology Co., Ltd.2024-04-05
NUNA LUX (NUNL528) (K233862)Premier North America, Inc.2024-03-01
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) (K233114)Shenzhen Idea Light Limited2024-01-12
LED Eye mask (EY-20R, A20, EY-20N) (K233556)Shenzhen Kaiyan Medical Equipment Co., Ltd.2024-01-04
Radiant Renewal Skincare Wand (HD-15, HD-15A) (K232863)Shenzhen Kaiyan Medical Equipment Co., Ltd.2023-12-13
Led Mask Platinum Exclusive MD (K232795)Stg24 Co., Ltd.2023-12-07
B.Light Clear Evo and B.Light Restore Evo (K223919)Bemer Int AG2023-09-23
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (K231555)iSMART Developments, Ltd.2023-07-27
TheraFace Mask (K230293)Therabody, Inc.2023-06-09
Infrared Heat (Model: E0221) (K223893)Light Tree Ventures Europe B.V.2023-05-16
myLEDmask (K223147)Myblend2023-05-14
LED Facial Mask (K230351)Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.2023-05-05
Q-Rejuvalight Pro Facewear (Model: P19-0023) (K230042)Light Tree Ventures Europe B.V.2023-04-28
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (K230124)Light Tree Ventures Europe B.V.2023-03-15
LED light therapy mask (FM-01, FM-02, FM-03) (K223544)Guangdong Newdermo Biotech Co., Ltd.2023-02-23
NIRA Model 2 (K222685)Dermal Photonics Corp2023-02-08
reVive Light Therapy® Wrinkle and Acne LED Device (K223482)Led Technologies, Inc.2022-12-21
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (K221775)Light Tree Ventures Europe B.V.2022-12-20
LED Eye Perfector, model: EY-36A, EY-36B (K221444)Light Tree Ventures Europe B.V.2022-12-08
LED Light Therapy Mask (model: MK66R-B) (K221946)Light Tree Ventures Europe B.V.2022-11-22
easy Claire (K223278)Y & J Bio Co., Ltd.2022-11-17
Led Mask Platinum Md (K222377)Cellreturn Co., Ltd.2022-11-03
reVive Light Therapy LED Cleansing System (K221430)Led Technologies, Inc.2022-07-27
Synergy Marble (Model: Opasm) (K220064)Yrs Group, Inc.2022-07-22
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