OHS
- 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.
510(k) clearances, last 3 years (84)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261602 | 2026-08-10 | Shenzhen Goodwind Technology Developme… | Eye Recovery Pro (PH-e03) | |
| K261601 | 2026-08-07 | Shenzhen Chuangtong Yigou Technology C… | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07… | |
| K261496 | 2026-08-04 | Duplex International Trading Limited | LED Light Therapy Masks (PE748, PE749, PE756) | |
| K261851 | 2026-08-04 | Shenzhen Qianyu Technology Co., Ltd. | LED Light Therapy Mask (JML1, JML1+JML2); LED Light … | |
| K261482 | 2026-07-31 | Led Intellectual Properties, LLC | LightStim for Wrinkles (1984); LightStim for Acne (2… | |
| K260598 | 2026-07-24 | iSMART Developments, Ltd. | 5 Wavelength LED Facemask (TN2508) | |
| K261407 | 2026-07-15 | Dongguan Miqiang Technology Co., Ltd. | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XP… | |
| K261473 | 2026-07-01 | Termosalud S.L. | Chromix | |
| K261052 | 2026-06-29 | Guangdong Newdermo Biotech Co., Ltd. | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, … | |
| K260946 | 2026-06-18 | Guangdong Newdermo Biotech Co., Ltd. | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K… | FDA |
| K254025 | 2026-06-16 | Shenzhen Kaiyan Medical Equipment Co.,… | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-18… | |
| K260715 | 2026-06-03 | The Beauty Tech Group, Ltd. | CurrentBody Skin LED Multi Light Therapy Mask (MK-11… | |
| K260415 | 2026-05-12 | Light Tree Ventures Europe B.V. | myLEDmask 2 (MJ-144) | |
| K260150 | 2026-04-22 | NOOANCE | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-… | |
| K260202 | 2026-03-23 | Guangdong Newdermo Biotech Co., Ltd. | LED Light Therapy Masks (LumiLips FAC07NA) | FDA |
| K260511 | 2026-03-16 | Shenzhen Ulike Smart Electronics Co., … | Ulike Reglow Light Therapy Device (UM10) | |
| K254079 | 2026-03-16 | Shenzhen Desida Technology Co., Ltd. | LED Light Therapy Mask (Models: T2, RLD10) | |
| K253874 | 2026-03-03 | Shenzhen Hanhua Opto Co., Ltd. | LED Therapy Light (COB1400, HP1800PRO) | |
| K253683 | 2026-02-20 | Foreo, Inc. | FAQ (LED Panel); FAQ (Dual LED Panel) | — |
| K254007 | 2026-02-12 | SZ KKS Silicone&Electronic Co., Ltd. | LED Light Therapy Silicone Face Mask (kks-225, kks-2… | |
| K253833 | 2026-01-30 | Shenzhen Jianchao Intelligent Technolo… | Facial & Body Beauty Device (model: INIA-BD001, INIA… | |
| K252603 | 2026-01-28 | Shenzhen Kaiyan Medical Equipment Co.,… | HIGHERDOSE Body Sculptor (Model: GS-03) | |
| K253712 | 2026-01-23 | Shenzhen Rainbow Technology Co., Ltd. | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-0… | |
| K253279 | 2025-12-24 | Heat IN A Click, LLC | Feather/numiere 05 06 07 (05) | |
| K253400 | 2025-12-24 | Shenzhen Saidi Light Therapy Technolog… | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W… | |
| K253135 | 2025-12-23 | Dongguan Yijiaming Technology Co., Ltd… | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V… | |
| K253086 | 2025-12-19 | Sunglor Technology Co., Ltd. | LED Light Therapy Device (Models: SG-FM, SG-FE) | |
| K253054 | 2025-12-19 | Shenzhen Xinlong Precision Plastic Mol… | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M1… | |
| K252983 | 2025-12-17 | Shenzhen Goodwind Technology Developme… | Wrinkle Retreat Pro Light Therapy Face Mask (Model: … | |
| K252994 | 2025-12-08 | Guangdong Ace-Tec Co., Ltd. | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3,… | |
| K252142 | 2025-12-05 | Shenzhen Siken 3D Technology Developme… | Multi-functional Facial Beauty Device (SKB-1703,SKB-… | |
| K252642 | 2025-11-19 | Shenzhen Dachi Communication Co., Ltd. | Microcurrent Facial Device (CEC101, EEI101) | |
| K253073 | 2025-11-19 | Sunglor Technology Co., Ltd. | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | |
| K252308 | 2025-11-13 | Atop Lighting Co., Ltd. | LED Beauty Mask (RLBXX) | |
| K252053 | 2025-10-27 | Touchbeauty Beauty & Health ( Shenzhen… | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF,… | |
| K252264 | 2025-10-17 | Shenzhen Zhenxing Ruitong Technology C… | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); ME… | |
| K252093 | 2025-10-16 | Merchsource, LLC | Light Therapy Mask (1019055) | |
| K252272 | 2025-10-09 | Shenzhen Kaiyan Medical Equipment Co.,… | ORA Method LED Gua Sha (GS-04) | |
| K251825 | 2025-10-01 | Shenzhen Ulike Smart Electronics Co., … | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U… | |
| K252096 | 2025-10-01 | Merchsource, LLC | Light Therapy Decollete Mask (1019135) | |
| K252189 | 2025-09-12 | Dongguan Yanxi Technology Co., Ltd. | LED Light Therapy Mask (2311, 2344, 2457, 2458) | |
| K251781 | 2025-09-04 | Shenzhen Kaiyan Medical Equipment Co.,… | KALA MINI 2.0 (KALA-04) | |
| K251588 | 2025-08-21 | Shenzhen Fittop Health Technology Co.,… | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM9… | |
| K251871 | 2025-08-15 | Heat IN A Click, LLC | FEATHER 01 02 03 04 (Model:01) | |
| K251012 | 2025-08-14 | Shenzhen Kaiyan Medical Equipment Co.,… | TRUDERMAL Pro (ZLD-390) | |
| K251667 | 2025-08-07 | Shenzhen Liyoutong Technology Co., Ltd… | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09… | |
| K250761 | 2025-07-11 | Shenzhen Kaiyan Medical Equipment Co.,… | KALA Therapy Wand (Model: KALA-03) | |
| K250966 | 2025-06-25 | Shenzhen Kaiyan Medical Equipment Co.,… | CurrentBody Skin LED Light Therapy Mask Series 2 (M… | |
| K243978 | 2025-06-20 | Shenzhen Sunsred Technology Co.,Ltd | LED Facial Mask | |
| K250880 | 2025-06-20 | Foshan Guangyu Weilai Medical Equipmen… | LED LIGHT MASK (A093) | |
| K250830 | 2025-06-09 | Shenzhen Sungrow Led Technology Co., L… | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, … | |
| K251042 | 2025-06-06 | Guangzhou Ahead Intelligent Technology… | Light Therapy System (M500, L6) | |
| K250581 | 2025-05-30 | Shenzhen Kaiyan Medical Equipment Co.,… | KALA Red Light Face Mask (KALA-01) | |
| K250532 | 2025-05-22 | Shenzhen Kaiyan Medical Equipment Co.,… | Solawave 2-in-1 Skincare Mini (Model: 61043) | |
| K244020 | 2025-05-01 | Shenzhen Qianyu Technology Co., Ltd. | Wrinkle Treatment Device (JM1, JM2B) | |
| K242151 | 2025-04-08 | Shenzhen Nuon Medical Equipment Co., L… | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,… | FDA |
| K242385 | 2025-04-07 | Shenzhen Borria Technology Co., Ltd. | LED Therapy Mask (MN1, M226) | |
| K250125 | 2025-03-24 | Xplr , Ltd. | LMNT O2 | |
| K250413 | 2025-03-18 | Shenzhen Perfect Idea Technology Limit… | Aglaia LED Beauty Device (BP-D2309) | — |
| K241947 | 2025-03-03 | Shenzhen Kaiyan Medical Equipment Co.,… | EnergyLounger (TY-01) | |
| K243330 | 2025-02-21 | Lyma Life , Ltd. | LYMA Laser PRO | |
| K242593 | 2025-02-14 | Shenzhen Kaiyan Medical Equipment Co.,… | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK… | |
| K243423 | 2025-01-28 | Shenzhen Rainbow Technology Co., Ltd. | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB… | FDA |
| K243492 | 2025-01-10 | Shenzhen Ulike Smart Electronics Co., … | Ulike Reglow Light Therapy Device (UM10) | |
| K242789 | 2025-01-02 | Dongguan Laiguang Electronic Technolog… | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005… | |
| K243040 | 2024-12-20 | Shenzhen Siken 3D Technology Developme… | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P… | |
| K242700 | 2024-12-19 | Shenzhen Nuon Medical Equipment Co., L… | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C… | |
| K242638 | 2024-11-27 | Shenzhen Walton Technology Co., Ltd. | LED Light Therapy Machine (G1, G3, G4, G6) | |
| K242796 | 2024-11-27 | Sharkninja Operating, LLC | CryoGlow (FW3XXXX) | FDA |
| K242382 | 2024-11-08 | iSMART Developments, Ltd. | décoLITE LED Device | |
| K241718 | 2024-10-28 | Shenzhen Aozemei Technology Co., Ltd. | Micro-current Facial Beauty Device (AM-810B, AM-810W… | |
| K241857 | 2024-10-11 | Dongguan Boyuan Intelligent Technology… | LED Light Therapy Device (KFB290, KFB291, KFB265, KF… | FDA |
| K241933 | 2024-09-27 | Shenzhen Kaiyan Medical Equipment Co.,… | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | FDA |
| K241102 | 2024-08-20 | Foreo, Inc. | Luna 4 plus | |
| K241203 | 2024-07-25 | Dongguan Hunter Electronic Technology … | PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, … | |
| K240378 | 2024-04-19 | Foreo, Inc. | FAQ 201, FAQ 202 | — |
| K240089 | 2024-04-10 | Shenzhen Kaiyan Medical Equipment Co.,… | Face Patches (MT-12MA, MT-12MC) | |
| K240360 | 2024-04-05 | Shenzhen Qianyu Technology Co., Ltd. | Wrinkle Treatment Device (JM2) | |
| K233862 | 2024-03-01 | Premier North America, Inc. | NUNA LUX (NUNL528) | |
| K233114 | 2024-01-12 | Shenzhen Idea Light Limited | LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-… | |
| K233556 | 2024-01-04 | Shenzhen Kaiyan Medical Equipment Co.,… | LED Eye mask (EY-20R, A20, EY-20N) | |
| K232863 | 2023-12-13 | Shenzhen Kaiyan Medical Equipment Co.,… | Radiant Renewal Skincare Wand (HD-15, HD-15A) | |
| K232795 | 2023-12-07 | Stg24 Co., Ltd. | Led Mask Platinum Exclusive MD | |
| K223919 | 2023-09-23 | Bemer Int AG | B.Light Clear Evo and B.Light Restore Evo |
Official FDA classification page: OHS
Classification and pathway per current FDA publications. Data from openFDA (CC0).