OHS

Light Based Over The Counter Wrinkle Reduction

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(84 件)

数据窗口为最近三年。最新一件:2026-08-10。

510(k) 号批准日期申请人器械名称摘要
K2616022026-08-10Shenzhen Goodwind Technology DevelopmeEye Recovery Pro (PH-e03)PDF
K2616012026-08-07Shenzhen Chuangtong Yigou Technology CLED Light Therapy Mask (M01, M02, M03, M05, M06, M07PDF
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 (2PDF
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, XPPDF
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-KFDA
K2540252026-06-16Shenzhen Kaiyan Medical Equipment Co.,LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-18PDF
K2607152026-06-03The Beauty Tech Group, Ltd.CurrentBody Skin LED Multi Light Therapy Mask (MK-11PDF
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-2PDF
K2538332026-01-30Shenzhen Jianchao Intelligent TechnoloFacial & Body Beauty Device (model: INIA-BD001, INIAPDF
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-0PDF
K2532792025-12-24Heat IN A Click, LLCFeather/numiere 05 06 07 (05)PDF
K2534002025-12-24Shenzhen Saidi Light Therapy TechnologLED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-WPDF
K2531352025-12-23Dongguan Yijiaming Technology Co., LtdLED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2VPDF
K2530862025-12-19Sunglor Technology Co., Ltd.LED Light Therapy Device (Models: SG-FM, SG-FE)PDF
K2530542025-12-19Shenzhen Xinlong Precision Plastic MolLED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M1PDF
K2529832025-12-17Shenzhen Goodwind Technology DevelopmeWrinkle 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 DevelopmeMulti-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 ( ShenzhenVITA Multi-Function Head Brush (TB-2443F, TB-2442AF,PDF
K2522642025-10-17Shenzhen Zhenxing Ruitong Technology CMEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEPDF
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, JD20UPDF
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, FCM9PDF
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., LtdLED Light Therapy Mask (M01, M02, M06, M07, M08, M09PDF
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 (MPDF
K2439782025-06-20Shenzhen Sunsred Technology Co.,LtdLED Facial MaskPDF
K2508802025-06-20Foshan Guangyu Weilai Medical EquipmenLED LIGHT MASK (A093)PDF
K2508302025-06-09Shenzhen Sungrow Led Technology Co., LLED Light Therapy Mask (G15, G15P, G15K, G11P, G11, PDF
K2510422025-06-06Guangzhou Ahead Intelligent TechnologyLight 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., LRadiant 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 LimitAglaia 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 (MKPDF
K2434232025-01-28Shenzhen Rainbow Technology Co., Ltd.LED Light Therapy Mask (Model(s): RB-008, RB-030, RBFDA
K2434922025-01-10Shenzhen Ulike Smart Electronics Co., Ulike Reglow Light Therapy Device (UM10)PDF
K2427892025-01-02Dongguan Laiguang Electronic TechnologBestqool LED Therapy Device (LMK-001,LMK-004,LMK-005PDF
K2430402024-12-20Shenzhen Siken 3D Technology DevelopmeLED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918PPDF
K2427002024-12-19Shenzhen Nuon Medical Equipment Co., LRadiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59CPDF
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-810WPDF
K2418572024-10-11Dongguan Boyuan Intelligent TechnologyLED Light Therapy Device (KFB290, KFB291, KFB265, KFFDA
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

其中 74 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。