OHS
- 产品代码
- OHS
- 器械名称
- Light Based Over The Counter Wrinkle Reduction
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4810
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 84 件
- 其中 Summary 已存档
- 74 份,可直接下载
- FDA 历史累计 510(k)
- 162 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
该代码近三年的 510(k)(84 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页: OHS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。