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OHS

Light Based Over The Counter Wrinkle Reduction

Product code
OHS
Device name
Light Based Over The Counter Wrinkle Reduction
Device class
Class 2
21 CFR
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
84
Summaries archived here
74 (direct download)
510(k) clearances (all years, FDA)
162 (all years; only the last 3 years are listed here)

FDA classification definition

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (84)

Last three years. Most recent: 2026-08-10.

NumberDecision dateApplicantDevice nameSummary
K2616022026-08-10Shenzhen Goodwind Technology Developme…Eye Recovery Pro (PH-e03)PDF
K2616012026-08-07Shenzhen Chuangtong Yigou Technology C…LED Light Therapy Mask (M01, M02, M03, M05, M06, M07…PDF
K2614962026-08-04Duplex International Trading LimitedLED Light Therapy Masks (PE748, PE749, PE756)PDF
K2618512026-08-04Shenzhen Qianyu Technology Co., Ltd.LED Light Therapy Mask (JML1, JML1+JML2); LED Light …PDF
K2614822026-07-31Led Intellectual Properties, LLCLightStim for Wrinkles (1984); LightStim for Acne (2…PDF
K2605982026-07-24iSMART Developments, Ltd.5 Wavelength LED Facemask (TN2508)PDF
K2614072026-07-15Dongguan Miqiang Technology Co., Ltd.XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XP…PDF
K2614732026-07-01Termosalud S.L.ChromixPDF
K2610522026-06-29Guangdong Newdermo Biotech Co., Ltd.LED Light Therapy Masks (LED Face Mask Pro FAC08NA, …PDF
K2609462026-06-18Guangdong Newdermo Biotech Co., Ltd.LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K…FDA
K2540252026-06-16Shenzhen Kaiyan Medical Equipment Co.,…LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-18…PDF
K2607152026-06-03The Beauty Tech Group, Ltd.CurrentBody Skin LED Multi Light Therapy Mask (MK-11…PDF
K2604152026-05-12Light Tree Ventures Europe B.V.myLEDmask 2 (MJ-144)PDF
K2601502026-04-22NOOANCELED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-…PDF
K2602022026-03-23Guangdong Newdermo Biotech Co., Ltd.LED Light Therapy Masks (LumiLips FAC07NA)FDA
K2605112026-03-16Shenzhen Ulike Smart Electronics Co., …Ulike Reglow Light Therapy Device (UM10)PDF
K2540792026-03-16Shenzhen Desida Technology Co., Ltd.LED Light Therapy Mask (Models: T2, RLD10)PDF
K2538742026-03-03Shenzhen Hanhua Opto Co., Ltd.LED Therapy Light (COB1400, HP1800PRO)PDF
K2536832026-02-20Foreo, Inc.FAQ™ (LED Panel); FAQ™ (Dual LED Panel)—
K2540072026-02-12SZ KKS Silicone&Electronic Co., Ltd.LED Light Therapy Silicone Face Mask (kks-225, kks-2…PDF
K2538332026-01-30Shenzhen Jianchao Intelligent Technolo…Facial & Body Beauty Device (model: INIA-BD001, INIA…PDF
K2526032026-01-28Shenzhen Kaiyan Medical Equipment Co.,…HIGHERDOSE Body Sculptor (Model: GS-03)PDF
K2537122026-01-23Shenzhen Rainbow Technology Co., Ltd.LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-0…PDF
K2532792025-12-24Heat IN A Click, LLCFeather/numiere 05 06 07 (05)PDF
K2534002025-12-24Shenzhen Saidi Light Therapy Technolog…LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W…PDF
K2531352025-12-23Dongguan Yijiaming Technology Co., Ltd…LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V…PDF
K2530862025-12-19Sunglor Technology Co., Ltd.LED Light Therapy Device (Models: SG-FM, SG-FE)PDF
K2530542025-12-19Shenzhen Xinlong Precision Plastic Mol…LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M1…PDF
K2529832025-12-17Shenzhen Goodwind Technology Developme…Wrinkle Retreat Pro Light Therapy Face Mask (Model: …PDF
K2529942025-12-08Guangdong Ace-Tec Co., Ltd.LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3,…PDF
K2521422025-12-05Shenzhen Siken 3D Technology Developme…Multi-functional Facial Beauty Device (SKB-1703,SKB-…PDF
K2526422025-11-19Shenzhen Dachi Communication Co., Ltd.Microcurrent Facial Device (CEC101, EEI101)PDF
K2530732025-11-19Sunglor Technology Co., Ltd.LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)PDF
K2523082025-11-13Atop Lighting Co., Ltd.LED Beauty Mask (RLBXX)PDF
K2520532025-10-27Touchbeauty Beauty & Health ( Shenzhen…VITA Multi-Function Head Brush (TB-2443F, TB-2442AF,…PDF
K2522642025-10-17Shenzhen Zhenxing Ruitong Technology C…MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); ME…PDF
K2520932025-10-16Merchsource, LLCLight Therapy Mask (1019055)PDF
K2522722025-10-09Shenzhen Kaiyan Medical Equipment Co.,…ORA Method LED Gua Sha (GS-04)PDF
K2518252025-10-01Shenzhen Ulike Smart Electronics Co., …Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U…PDF
K2520962025-10-01Merchsource, LLCLight Therapy Decollete Mask (1019135)PDF
K2521892025-09-12Dongguan Yanxi Technology Co., Ltd.LED Light Therapy Mask (2311, 2344, 2457, 2458)PDF
K2517812025-09-04Shenzhen Kaiyan Medical Equipment Co.,…KALA MINI 2.0 (KALA-04)PDF
K2515882025-08-21Shenzhen Fittop Health Technology Co.,…LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM9…PDF
K2518712025-08-15Heat IN A Click, LLCFEATHER 01 02 03 04 (Model:01)PDF
K2510122025-08-14Shenzhen Kaiyan Medical Equipment Co.,…TRUDERMAL Pro (ZLD-390)PDF
K2516672025-08-07Shenzhen Liyoutong Technology Co., Ltd…LED Light Therapy Mask (M01, M02, M06, M07, M08, M09…PDF
K2507612025-07-11Shenzhen Kaiyan Medical Equipment Co.,…KALA Therapy Wand (Model: KALA-03)PDF
K2509662025-06-25Shenzhen Kaiyan Medical Equipment Co.,…CurrentBody Skin™ LED Light Therapy Mask Series 2 (M…PDF
K2439782025-06-20Shenzhen Sunsred Technology Co.,LtdLED Facial MaskPDF
K2508802025-06-20Foshan Guangyu Weilai Medical Equipmen…LED LIGHT MASK (A093)PDF
K2508302025-06-09Shenzhen Sungrow Led Technology Co., L…LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, …PDF
K2510422025-06-06Guangzhou Ahead Intelligent Technology…Light Therapy System (M500, L6)PDF
K2505812025-05-30Shenzhen Kaiyan Medical Equipment Co.,…KALA Red Light Face Mask (KALA-01)PDF
K2505322025-05-22Shenzhen Kaiyan Medical Equipment Co.,…Solawave 2-in-1 Skincare Mini (Model: 61043)PDF
K2440202025-05-01Shenzhen Qianyu Technology Co., Ltd.Wrinkle Treatment Device (JM1, JM2B)PDF
K2421512025-04-08Shenzhen Nuon Medical Equipment Co., L…Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,…FDA
K2423852025-04-07Shenzhen Borria Technology Co., Ltd.LED Therapy Mask (MN1, M226)PDF
K2501252025-03-24Xplr , Ltd.LMNT O2PDF
K2504132025-03-18Shenzhen Perfect Idea Technology Limit…Aglaia LED Beauty Device (BP-D2309)—
K2419472025-03-03Shenzhen Kaiyan Medical Equipment Co.,…EnergyLounger (TY-01)PDF
K2433302025-02-21Lyma Life , Ltd.LYMA Laser PROPDF
K2425932025-02-14Shenzhen Kaiyan Medical Equipment Co.,…CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK…PDF
K2434232025-01-28Shenzhen Rainbow Technology Co., Ltd.LED Light Therapy Mask (Model(s): RB-008, RB-030, RB…FDA
K2434922025-01-10Shenzhen Ulike Smart Electronics Co., …Ulike Reglow Light Therapy Device (UM10)PDF
K2427892025-01-02Dongguan Laiguang Electronic Technolog…Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005…PDF
K2430402024-12-20Shenzhen Siken 3D Technology Developme…LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P…PDF
K2427002024-12-19Shenzhen Nuon Medical Equipment Co., L…Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C…PDF
K2426382024-11-27Shenzhen Walton Technology Co., Ltd.LED Light Therapy Machine (G1, G3, G4, G6)PDF
K2427962024-11-27Sharkninja Operating, LLCCryoGlow (FW3XXXX)FDA
K2423822024-11-08iSMART Developments, Ltd.décoLITE LED DevicePDF
K2417182024-10-28Shenzhen Aozemei Technology Co., Ltd.Micro-current Facial Beauty Device (AM-810B, AM-810W…PDF
K2418572024-10-11Dongguan Boyuan Intelligent Technology…LED Light Therapy Device (KFB290, KFB291, KFB265, KF…FDA
K2419332024-09-27Shenzhen Kaiyan Medical Equipment Co.,…HIGHERDOSE Red and Infrared Light Mask (MK66-L)FDA
K2411022024-08-20Foreo, Inc.Luna 4 plusPDF
K2412032024-07-25Dongguan Hunter Electronic Technology …PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, …PDF
K2403782024-04-19Foreo, Inc.FAQ™ 201, FAQ™ 202—
K2400892024-04-10Shenzhen Kaiyan Medical Equipment Co.,…Face Patches (MT-12MA, MT-12MC)PDF
K2403602024-04-05Shenzhen Qianyu Technology Co., Ltd.Wrinkle Treatment Device (JM2)PDF
K2338622024-03-01Premier North America, Inc.NUNA LUX (NUNL528)PDF
K2331142024-01-12Shenzhen Idea Light LimitedLED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-…PDF
K2335562024-01-04Shenzhen Kaiyan Medical Equipment Co.,…LED Eye mask (EY-20R, A20, EY-20N)PDF
K2328632023-12-13Shenzhen Kaiyan Medical Equipment Co.,…Radiant Renewal Skincare Wand (HD-15, HD-15A)PDF
K2327952023-12-07Stg24 Co., Ltd.Led Mask Platinum Exclusive MDPDF
K2239192023-09-23Bemer Int AGB.Light Clear Evo and B.Light Restore EvoPDF

74 summaries are archived here for direct download.

Official FDA classification page: OHS
Classification and pathway per current FDA publications. Data from openFDA (CC0).