OHT
- 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.
该代码近三年的 510(k)(71 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261705 | 2026-08-10 | Shenzhen Jianchao Intelligent Technolo… | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | |
| K261325 | 2026-05-21 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S… | |
| K260594 | 2026-05-20 | Shenzhen Xiazhifeng Electronic Co., Lt… | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B5… | |
| K260742 | 2026-05-05 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S… | FDA |
| K260518 | 2026-04-21 | Shenzhen Semlamp Intelligent Technolog… | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330… | |
| K254047 | 2026-03-11 | Shenzhen Chuangtong Yigou Technology C… | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro,… | |
| K253666 | 2026-02-23 | Shenzhen Mlay Intelligent Technology C… | IPL Hair Removal Device (Models: T31A, T32A) | |
| K253881 | 2025-12-29 | Shenzhen Fansizhe Science and Technolo… | Intense Pulsed Light (IPL) System (Models: T033KQ, T… | |
| K253754 | 2025-12-23 | Philips Consumer Lifestyle B.V. | Philips Lumea IPL | |
| K253304 | 2025-11-25 | Dongguan Lide Electric Appliance Co., … | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11… | |
| K253035 | 2025-11-19 | Gu'An Yeolight Smart Electronics Co., … | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | FDA |
| K252618 | 2025-11-14 | Alovea Healthcare Co. , Ltd. | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | |
| K252234 | 2025-10-14 | Shenzhen Qiaochengli Technology Co., L… | IPL Home Use Hair Removal Device (Models: FDA11, FDA… | |
| K252209 | 2025-10-10 | Foshan Jindi Electric Appliance Co., L… | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023… | |
| K251398 | 2025-10-02 | Shenzhen Enmind Technology Co., Ltd. | IPL Hair Removal Device (IPL-001, IPL-002) | FDA |
| K252804 | 2025-10-01 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S… | — |
| K251914 | 2025-09-15 | Miley Technology (Hebei) Co., Ltd. | IPL Hair Removal Device (MLY-M011); IPL Hair Removal… | |
| K251176 | 2025-08-14 | Shenzhen Mlay Intelligent Technology C… | IPL Hair Removal Device (Model(s): T14B, T16B, T19B,… | FDA |
| K251707 | 2025-08-01 | Shenzhen Huachuangtong Industrial Co.,… | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208… | |
| K251984 | 2025-07-24 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S… | |
| K251173 | 2025-07-14 | Shenzhen Fansizhe Science and Technolo… | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T… | |
| K250942 | 2025-07-11 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S… | |
| K251000 | 2025-06-30 | Shenzhen Chuangtong Yigou Technology C… | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-2… | |
| K243036 | 2025-06-15 | Bestway Plastic and Metal Products , L… | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, … | |
| K250384 | 2025-05-23 | El Global Trade, Ltd. | IPL400 | |
| K250938 | 2025-05-23 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 C… | |
| K243017 | 2025-05-06 | Foshan Newface Electronic Technology C… | IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10… | FDA |
| K250253 | 2025-05-06 | Dongguan Boyuan Intelligent Technology… | IPL Hair Removal Device (KCA511/KCA516/KCA522) | |
| K250194 | 2025-03-26 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S… | |
| K250131 | 2025-03-19 | Mustech Electronics Co., Limited | IPL Hair Removal Device (M8011, M8012, M8013, M8015,… | |
| K250171 | 2025-03-19 | Shenzhen Yang WO Electronic Co., Ltd. | IPL Hair Removal Device (BE965A, BE965B, BE965C) | |
| K243453 | 2025-02-10 | Philips Consumer Lifestyle B.V. | Philips Lumea IPL | — |
| K243085 | 2024-12-21 | Zhuzhou Goldenhot Medical Technology C… | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, … | |
| K241998 | 2024-12-13 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 R… | |
| K242710 | 2024-12-06 | Shenzhen Jianchao Intelligent Technolo… | Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C1… | |
| K243362 | 2024-11-27 | Cyden Limited | SmoothSkin Pure Switch (SSC1) | |
| K242595 | 2024-11-07 | Shenzhen Greatro Electronic Technology… | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF… | |
| K242039 | 2024-11-06 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20… | FDA |
| K243030 | 2024-10-25 | Ulike Co., Ltd. | Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI0… | |
| K242197 | 2024-10-17 | Shenzhen Huaruibo Electric Appliances … | IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max… | FDA |
| K241834 | 2024-09-23 | Shenzhen Yang WO Electronic Co., Ltd. | IPL Hair Removal Device (BE932C, BE932D, BE932E) | |
| K241205 | 2024-09-09 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,… | |
| K241881 | 2024-08-29 | Shenzhen Junmei Technology Co., Ltd. | IPL Hair Removal Device (JM-843, JM-865, JM-638) | |
| K240016 | 2024-07-10 | Shenzhen Jianrong Biomedical Electroni… | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | |
| K241343 | 2024-07-09 | Shenzhen Lescolton Electrical Applianc… | IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B… | FDA |
| K241120 | 2024-06-24 | Qiaocheng LI (Dongguan) Medical Instru… | Intense pulsed light therapy apparatus (FDA01, FDA02… | |
| K240649 | 2024-06-21 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 D… | — |
| K240583 | 2024-06-18 | Shenzhen Beauty Every Moment Intellige… | IPL Home Use Hair Removal Device (D-1199, D-T099, D-… | |
| K240969 | 2024-05-31 | Shenzhen Semlamp Intelligent Technolog… | IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B3… | |
| K241106 | 2024-05-22 | Shenzhen Mlay Intelligent Technology C… | Ice Cooling IPL Home Use Hair Removal Device (Model(… | |
| K240093 | 2024-04-24 | Shenzhen Shuge Medical Beauty Devices … | IPL Home Use Hair Removal Device (SJ15) | |
| K240652 | 2024-04-04 | Shenzhen Ulike Smart Electronics Co., … | Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 P… | — |
| K240282 | 2024-04-03 | Dongguan Boyuan Intelligent Technology… | IPL Hair Removal Device (model: KCA450, KCA446, KCA5… | — |
| K240587 | 2024-03-29 | Cyden Limited | SmoothSkin Pure Unplugged (SSB3) | |
| K240264 | 2024-03-08 | Shenzhen Mlay Intelligent Technology C… | Home Use Hair Removal Device (Model(s):T10A, T10B, T… | |
| K233887 | 2024-01-22 | Shenzhen Ulike Smart Electronics Co., … | IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, U… | — |
| K233664 | 2024-01-11 | Shenzhen Ulike Smart Electronics Co., … | IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, … | — |
| K233679 | 2024-01-05 | Shenzhen Ulike Smart Electronics Co., … | IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI0… | — |
| K233782 | 2023-12-20 | Cyden Limited | SmoothSkin Pure Adapt (SSG3) | |
| K232939 | 2023-12-15 | Shenzhen Borria Technology Co., Ltd. | IPL Hair Removal Device | FDA |
| K232846 | 2023-12-07 | Shenzhen Meik Beauty Industry Co., Ltd… | Light Based Hair Removal Device | |
| K232932 | 2023-12-04 | Shenzhen Greatro Electronic Technology… | Intense Pulse Light Therapeutic Apparatus | |
| K232575 | 2023-11-20 | Shenzhen Jianchao Intelligent Technolo… | Hair Removal Device, Model(s): R2815-G Pro, R2815-G | |
| K232845 | 2023-11-14 | Shenzhen Siken 3D Technology Developme… | IPL Cooling Hair Removal Device | |
| K232499 | 2023-10-11 | Shenzhen Lescolton Electrical Applianc… | IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | |
| K232056 | 2023-10-06 | Dongguan Lide Electric Appliance Co., … | IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB… | |
| K232274 | 2023-09-28 | Lumenessa Corp | IPL hair removal device | FDA |
| K231977 | 2023-09-25 | Foreo, Inc. | PEACH 2, PEACH 2 Duo, PEACH 2 go | — |
| K232183 | 2023-09-22 | Shenzhen Koli Technology Co.,Ltd | IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T… | |
| K232124 | 2023-09-14 | Shenzhen Wochuan Electronic Co., Ltd. | IPL Hair Removal, Model: W-1095, W-1098 | |
| K230362 | 2023-09-11 | Shenzhen Leaflife Technology Co., Ltd. | Planar LED mate |
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。