FDA records / LED masks & light therapy

LED masks & light therapy: FDA records

All loaded records in the verified product-code scope. Some refer to professional devices or discontinued models. Inclusion does not establish home use or match a retail product.


163 records

SESE: substantially equivalent 510(k) decision.

LED masks & light therapy records, newest decision first
Device nameApplicantRecordCodeDecision dateDecision
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.K260767OHS2026-08-31SESE
Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261602OHS2026-08-10SESE
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261601OHS2026-08-07SESE
LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261496OHS2026-08-04SESE
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.K261851OHS2026-08-04SESE
LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK261482OHS2026-07-31SESE
5 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.K260598OHS2026-07-24SESE
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.K261407OHS2026-07-15SESE
ChromixTermosalud S.L.K261473OHS2026-07-01SESE
LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.K261052OHS2026-06-29SESE
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.K260946OHS2026-06-18SESE
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.K254025OHS2026-06-16SESE
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.K260715OHS2026-06-03SESE
myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.K260415OHS2026-05-12SESE
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)NOOANCEK260150OHS2026-04-22SESE
LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd.K260202OHS2026-03-23SESE
LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.K254079OHS2026-03-16SESE
Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.K260511OHS2026-03-16SESE
LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.K253874OHS2026-03-03SESE
FAQ™ (LED Panel); FAQ™ (Dual LED Panel)Foreo, Inc.K253683OHS2026-02-20SESE
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)SZ KKS Silicone&Electronic Co., Ltd.K254007OHS2026-02-12SESE
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.K253833OHS2026-01-30SESE
HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.K252603OHS2026-01-28SESE
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.K253712OHS2026-01-23SESE
Feather/numiere 05 06 07 (05)Heat IN A Click, LLCK253279OHS2025-12-24SESE
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.K253400OHS2025-12-24SESE
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.K253135OHS2025-12-23SESE
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.K253054OHS2025-12-19SESE
LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.K253086OHS2025-12-19SESE
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.K252983OHS2025-12-17SESE
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)Guangdong Ace-Tec Co., Ltd.K252994OHS2025-12-08SESE
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.K252142OHS2025-12-05SESE
Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.K252642OHS2025-11-19SESE
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.K253073OHS2025-11-19SESE
LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.K252308OHS2025-11-13SESE
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., LtdK252053OHS2025-10-27SESE
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.K252264OHS2025-10-17SESE
Light Therapy Mask (1019055)Merchsource, LLCK252093OHS2025-10-16SESE
ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.K252272OHS2025-10-09SESE
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.K251825OHS2025-10-01SESE
Light Therapy Decollete Mask (1019135)Merchsource, LLCK252096OHS2025-10-01SESE
LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd.K252189OHS2025-09-12SESE
KALA MINI 2.0 (KALA-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251781OHS2025-09-04SESE
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.K251588OHS2025-08-21SESE
FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLCK251871OHS2025-08-15SESE
TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251012OHS2025-08-14SESE
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.K251667OHS2025-08-07SESE
KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.K250761OHS2025-07-11SESE
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.K250966OHS2025-06-25SESE
LED Facial MaskShenzhen Sunsred Technology Co.,LtdK243978OHS2025-06-20SESE
LED LIGHT MASK (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.K250880OHS2025-06-20SESE
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)Shenzhen Sungrow Led Technology Co., Ltd.K250830OHS2025-06-09SESE
Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.K251042OHS2025-06-06SESE
KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.K250581OHS2025-05-30SESE
Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.K250532OHS2025-05-22SESE
Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.K244020OHS2025-05-01SESE
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.K242151OHS2025-04-08SESE
LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd.K242385OHS2025-04-07SESE
LMNT O2Xplr , Ltd.K250125OHS2025-03-24SESE
Aglaia LED Beauty Device (BP-D2309)Shenzhen Perfect Idea Technology LimitedK250413OHS2025-03-18SESE
EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.K241947OHS2025-03-03SESE
LYMA Laser PROLyma Life , Ltd.K243330OHS2025-02-21SESE
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.K242593OHS2025-02-14SESE
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.K243423OHS2025-01-28SESE
Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.K243492OHS2025-01-10SESE
Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.K242789OHS2025-01-02SESE
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.K243040OHS2024-12-20SESE
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.K242700OHS2024-12-19SESE
LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd.K242638OHS2024-11-27SESE
CryoGlow (FW3XXXX)Sharkninja Operating, LLCK242796OHS2024-11-27SESE
décoLITE LED DeviceiSMART Developments, Ltd.K242382OHS2024-11-08SESE
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.K241718OHS2024-10-28SESE
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,LtdK241857OHS2024-10-11SESE
HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.K241933OHS2024-09-27SESE
Luna 4 plusForeo, Inc.K241102OHS2024-08-20SESE
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.K241203OHS2024-07-25SESE
FAQ™ 201, FAQ™ 202Foreo, Inc.K240378OHS2024-04-19SESE
Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.K240089OHS2024-04-10SESE
Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.K240360OHS2024-04-05SESE
NUNA LUX (NUNL528)Premier North America, Inc.K233862OHS2024-03-01SESE
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light LimitedK233114OHS2024-01-12SESE
LED Eye mask (EY-20R, A20, EY-20N)Shenzhen Kaiyan Medical Equipment Co., Ltd.K233556OHS2024-01-04SESE
Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.K232863OHS2023-12-13SESE
Led Mask Platinum Exclusive MDStg24 Co., Ltd.K232795OHS2023-12-07SESE
B.Light Clear Evo and B.Light Restore EvoBemer Int AGK223919OHS2023-09-23SESE
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.K231555OHS2023-07-27SESE
TheraFace MaskTherabody, Inc.K230293OHS2023-06-09SESE
Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.K223893OHS2023-05-16SESE
myLEDmaskMyblendK223147OHS2023-05-14SESE
LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.K230351OHS2023-05-05SESE
Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.K230042OHS2023-04-28SESE
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)Light Tree Ventures Europe B.V.K230124OHS2023-03-15SESE
LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.K223544OHS2023-02-23SESE
NIRA Model 2Dermal Photonics CorpK222685OHS2023-02-08SESE
reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.K223482OHS2022-12-21SESE
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.K221775OHS2022-12-20SESE
LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.K221444OHS2022-12-08SESE
LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.K221946OHS2022-11-22SESE
easy ClaireY & J Bio Co., Ltd.K223278OHS2022-11-17SESE
Led Mask Platinum MdCellreturn Co., Ltd.K222377OHS2022-11-03SESE
reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.K221430OHS2022-07-27SESE
Synergy Marble (Model: Opasm)Yrs Group, Inc.K220064OHS2022-07-22SESE
Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.K221151OHS2022-07-19SESE
Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO , Ltd.K220168OHS2022-05-17SESE
Trinity Plus Wrinkle ReducerCarol Cole Company Dba NufaceK212947OHS2022-04-02SESE
Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading LimitedK214101OHS2022-03-23SESE
LYMA LaserLyma Life , Ltd.K210823OHS2022-03-18SESE
easy ClaireY & J Bio Co., Ltd.K213285OHS2022-03-03SESE
LightStim ElipsaLed Intellectual Properties, LLCK212771OHS2022-01-26SESE
ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.K213841OHS2022-01-06SESE
Oren LED Perioral Light Therapy SystemShenzhen Kaiyan Medical CO , Ltd.K213024OHS2021-12-22SESE
TheraFace LEDTheragun, Inc.K212155OHS2021-12-21SESE
reVive Light Therapy EssentialsLed Technologies, Inc.K210965OHS2021-12-15SESE
Dermalux Flex MDAesthetic Technology, Ltd.K212275OHS2021-11-18SESE
Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty MachineNingbo Hesi Electric Co., Ltd.K200983OHS2021-07-14SESE
Aduro Light Beauty MaskShenzhen Kaiyan Medical CO , Ltd.K202390OHS2021-07-14SESE
SynergyYrs Group, Inc.K210954OHS2021-06-29SESE
Carewear Firefly Wrinkle ReductionCarewear Corp.K202442OHS2020-11-19SESE
Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.K201107OHS2020-06-22SESE
faceLITEIsmart Marketing Svcs, Ltd.K191629OHS2019-09-12SESE
MMSphereGalactic Beauty, LLCK190443OHS2019-06-24SESE
dpl FacewareLed Technologies, Inc.K183247OHS2019-03-14SESE
LG PRA.L DERMA LED MASKLg Electronics.IncK183671OHS2019-01-22SESE
POLY REJUVMedtek Skincare, LLCK180875OHS2018-09-14SESE
Avologi ENEOPremier North America, Inc.K181659OHS2018-07-26SESE
Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.K180856OHS2018-06-19SESE
ELEVARE, PERFECTIO 4Omm Imports D/B/A Zero GravityK172909OHS2018-06-07SESE
reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.K180445OHS2018-05-15SESE
dpl IIa PanelLed Technologies, Inc.K180320OHS2018-04-03SESE
reVive PerioralLed Technologies, Inc.K172662OHS2018-01-09SESE
BIOPHOTAS CELLUMA3Biophotas, Inc.K171323OHS2017-09-01SESE
LG BEAUTY LED MASKLg ElectronicsK170984OHS2017-08-23SESE
dpl SpectraLiteLed Technologies, Inc.K171386OHS2017-08-07SESE
dpl II PanelLed Technologies, Inc.K171390OHS2017-08-03SESE
NIRA Beauty Skin LaserDermal Photonics CorporationK163137OHS2017-07-12SESE
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLCK163329OHS2017-04-14SESE
Silk'n HSTHome Skinovations , Ltd.K162784OHS2017-03-25SESE
RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.K162489OHS2017-01-13SESE
BrightTanda Beauty Canada, Inc.K161849OHS2016-07-29SESE
Perfectio LED infrared deviceOmm Imports Inc Dba Zero GravityK152332OHS2016-02-25SESE
StrialiteCentre Light Solutions, LLCK151337OHS2016-02-24SESE
LightStim Professional 2-Panel LightLed Intellectual Properties, LLCK151336OHS2015-10-23SESE
LightStim Professional 2-Panel LightLed Intellectual Properties, LLCK150098OHS2015-04-09SESE
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLESLed Technologies, LLCK141181OHS2015-03-31SESE
PRO X OTC 5La Lumiere, LLCK140471OHS2015-01-15SESE
REJUVALITE MDTrophy Skin, Inc.K133896OHS2014-11-13SESE
NUTRA LIGHT REDNutra Luxe MD, LLCK141308OHS2014-08-20SESE
STARLITE-OM, LIGHT EFFECTS, THIBIANTPs Advanced EngineeringK133546OHS2014-08-06SESE
SONILASE LIGHT THERAPY DEVICEBiorenew Labs, LLCK132613OHS2014-02-05SESE
ILUMINAGE SKIN SMOOTHING LASERCynosure, Inc.K133473OHS2014-01-15SESE
YOUNG AGAINEspansione Marketing S.P.AK124064OHS2013-12-19SESE
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICESilverbay, LLC, D/B/A Quasar Bio-TechK130225OHS2013-07-11SESE
TRINITY WRINKLE REMOVERCarol Cole CompanyK120560OHS2012-11-06SESE
C100 WRINKLE REDUCTION DEVICESilver Bay, LLCK112362OHS2012-08-14SESE
ILUMINAGE DIODE LASERCynosure, Inc.K111454OHS2012-07-05SESE
LIGHT FOR WRINKLESLed Intellectual Properties, LLCK120775OHS2012-06-04SESE
SILK'N FXHome Skinovations , Ltd.K110301OHS2011-08-19SESE
TANDA MAX OTC SYSTEMPharos Life CorporationK110735OHS2011-08-03SESE
DPL NUVELed Technologies, LLCK101382OHS2010-11-09SESE
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTCLed Intellectual Properties, LLCK101190OHS2010-07-01SESE
STAR-LITE -LM, MODEL SL8809Ps Advanced EngineeringK092460OHS2010-03-05SESE
OMNILUX NEW-UPhoto Therapeutics, Inc.K072459OHS2008-03-03SESE
GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICELight Bioscience, LLCK062991OHS2008-02-15SESE