OHT

Light Based Over-The-Counter Hair Removal

产品代码
OHT
器械名称
Light Based Over-The-Counter Hair Removal
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)
71 件
其中 Summary 已存档
52 份,可直接下载
FDA 历史累计 510(k)
163 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

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)(71 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
K2617052026-08-10Shenzhen Jianchao Intelligent Technolo…Hair Removal Device (R3C16-G Pro, R3C16-V Pro)PDF
K2613252026-05-21Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S…PDF
K2605942026-05-20Shenzhen Xiazhifeng Electronic Co., Lt…IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B5…PDF
K2607422026-05-05Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S…FDA
K2605182026-04-21Shenzhen Semlamp Intelligent Technolog…IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330…PDF
K2540472026-03-11Shenzhen Chuangtong Yigou Technology C…Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro,…PDF
K2536662026-02-23Shenzhen Mlay Intelligent Technology C…IPL Hair Removal Device (Models: T31A, T32A)PDF
K2538812025-12-29Shenzhen Fansizhe Science and Technolo…Intense Pulsed Light (IPL) System (Models: T033KQ, T…PDF
K2537542025-12-23Philips Consumer Lifestyle B.V.Philips Lumea IPLPDF
K2533042025-11-25Dongguan Lide Electric Appliance Co., …IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11…PDF
K2530352025-11-19Gu'An Yeolight Smart Electronics Co., …IPL Hair Removal Device (SYL001AZ, SYL002AZ)FDA
K2526182025-11-14Alovea Healthcare Co. , Ltd.IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)PDF
K2522342025-10-14Shenzhen Qiaochengli Technology Co., L…IPL Home Use Hair Removal Device (Models: FDA11, FDA…PDF
K2522092025-10-10Foshan Jindi Electric Appliance Co., L…IPL Home Use Hair Removal Device (JD-TM016, JD-TM023…PDF
K2513982025-10-02Shenzhen Enmind Technology Co., Ltd.IPL Hair Removal Device (IPL-001, IPL-002)FDA
K2528042025-10-01Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S…
K2519142025-09-15Miley Technology (Hebei) Co., Ltd.IPL Hair Removal Device (MLY-M011); IPL Hair Removal…PDF
K2511762025-08-14Shenzhen Mlay Intelligent Technology C…IPL Hair Removal Device (Model(s): T14B, T16B, T19B,…FDA
K2517072025-08-01Shenzhen Huachuangtong Industrial Co.,…IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208…PDF
K2519842025-07-24Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S…PDF
K2511732025-07-14Shenzhen Fansizhe Science and Technolo…Intense Pulsed Light (IPL) System (T033KQ, T033KD, T…PDF
K2509422025-07-11Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S…PDF
K2510002025-06-30Shenzhen Chuangtong Yigou Technology C…Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-2…PDF
K2430362025-06-15Bestway Plastic and Metal Products , L…IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, …PDF
K2503842025-05-23El Global Trade, Ltd.IPL400PDF
K2509382025-05-23Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 C…PDF
K2430172025-05-06Foshan Newface Electronic Technology C…IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10…FDA
K2502532025-05-06Dongguan Boyuan Intelligent Technology…IPL Hair Removal Device (KCA511/KCA516/KCA522)PDF
K2501942025-03-26Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S…PDF
K2501312025-03-19Mustech Electronics Co., LimitedIPL Hair Removal Device (M8011, M8012, M8013, M8015,…PDF
K2501712025-03-19Shenzhen Yang WO Electronic Co., Ltd.IPL Hair Removal Device (BE965A, BE965B, BE965C)PDF
K2434532025-02-10Philips Consumer Lifestyle B.V.Philips Lumea IPL
K2430852024-12-21Zhuzhou Goldenhot Medical Technology C…IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, …PDF
K2419982024-12-13Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 R…PDF
K2427102024-12-06Shenzhen Jianchao Intelligent Technolo…Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C1…PDF
K2433622024-11-27Cyden LimitedSmoothSkin Pure Switch (SSC1)PDF
K2425952024-11-07Shenzhen Greatro Electronic Technology…Intense Pulse Light Therapeutic Apparatus (IPL-18 BF…PDF
K2420392024-11-06Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20…FDA
K2430302024-10-25Ulike Co., Ltd.Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI0…PDF
K2421972024-10-17Shenzhen Huaruibo Electric Appliances …IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max…FDA
K2418342024-09-23Shenzhen Yang WO Electronic Co., Ltd.IPL Hair Removal Device (BE932C, BE932D, BE932E)PDF
K2412052024-09-09Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,…PDF
K2418812024-08-29Shenzhen Junmei Technology Co., Ltd.IPL Hair Removal Device (JM-843, JM-865, JM-638)PDF
K2400162024-07-10Shenzhen Jianrong Biomedical Electroni…IPL Hair Removal Device (YT01,YT02,YT03,YT04)PDF
K2413432024-07-09Shenzhen Lescolton Electrical Applianc…IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B…FDA
K2411202024-06-24Qiaocheng LI (Dongguan) Medical Instru…Intense pulsed light therapy apparatus (FDA01, FDA02…PDF
K2406492024-06-21Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 D…
K2405832024-06-18Shenzhen Beauty Every Moment Intellige…IPL Home Use Hair Removal Device (D-1199, D-T099, D-…PDF
K2409692024-05-31Shenzhen Semlamp Intelligent Technolog…IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B3…PDF
K2411062024-05-22Shenzhen Mlay Intelligent Technology C…Ice Cooling IPL Home Use Hair Removal Device (Model(…PDF
K2400932024-04-24Shenzhen Shuge Medical Beauty Devices …IPL Home Use Hair Removal Device (SJ15)PDF
K2406522024-04-04Shenzhen Ulike Smart Electronics Co., …Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 P…
K2402822024-04-03Dongguan Boyuan Intelligent Technology…IPL Hair Removal Device (model: KCA450, KCA446, KCA5…
K2405872024-03-29Cyden LimitedSmoothSkin Pure Unplugged (SSB3)PDF
K2402642024-03-08Shenzhen Mlay Intelligent Technology C…Home Use Hair Removal Device (Model(s):T10A, T10B, T…PDF
K2338872024-01-22Shenzhen Ulike Smart Electronics Co., …IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, U…
K2336642024-01-11Shenzhen Ulike Smart Electronics Co., …IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, …
K2336792024-01-05Shenzhen Ulike Smart Electronics Co., …IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI0…
K2337822023-12-20Cyden LimitedSmoothSkin Pure Adapt (SSG3)PDF
K2329392023-12-15Shenzhen Borria Technology Co., Ltd.IPL Hair Removal DeviceFDA
K2328462023-12-07Shenzhen Meik Beauty Industry Co., Ltd…Light Based Hair Removal DevicePDF
K2329322023-12-04Shenzhen Greatro Electronic Technology…Intense Pulse Light Therapeutic ApparatusPDF
K2325752023-11-20Shenzhen Jianchao Intelligent Technolo…Hair Removal Device, Model(s): R2815-G Pro, R2815-GPDF
K2328452023-11-14Shenzhen Siken 3D Technology Developme…IPL Cooling Hair Removal DevicePDF
K2324992023-10-11Shenzhen Lescolton Electrical Applianc…IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)PDF
K2320562023-10-06Dongguan Lide Electric Appliance Co., …IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB…PDF
K2322742023-09-28Lumenessa CorpIPL hair removal deviceFDA
K2319772023-09-25Foreo, Inc.PEACH 2, PEACH 2 Duo, PEACH 2 go
K2321832023-09-22Shenzhen Koli Technology Co.,LtdIPL Hair Removal Device, Model(s): T1, T2, T3, T7, T…PDF
K2321242023-09-14Shenzhen Wochuan Electronic Co., Ltd.IPL Hair Removal, Model: W-1095, W-1098PDF
K2303622023-09-11Shenzhen Leaflife Technology Co., Ltd.Planar LED matePDF

其中 52 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: OHT
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。