OHT · Light Based Over-The-Counter Hair Removal
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | OHT |
|---|---|
| Device Name | Light Based Over-The-Counter Hair Removal |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 160)
Showing 20 most recent of 160 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | Shenzhen Ulike Smart Electronics Co., Ltd. | May 5, 2026 | SESE |
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | Apr 21, 2026 | SESE |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Mar 11, 2026 | SESE |
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | Feb 23, 2026 | SESE |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science and Technology Co., Ltd. | Dec 29, 2025 | SESE |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | Dec 23, 2025 | SESE |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. | Nov 25, 2025 | SESE |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'An Yeolight Smart Electronics Co., Ltd. | Nov 19, 2025 | SESE |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. | Nov 14, 2025 | SESE |
| K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) | Shenzhen Qiaochengli Technology Co., Ltd. | Oct 14, 2025 | SESE |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. | Oct 10, 2025 | SESE |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. | Oct 2, 2025 | SESE |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co., Ltd. | Oct 1, 2025 | SESE |
| K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | Miley Technology (Hebei) Co., Ltd. | Sep 15, 2025 | SESE |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | Aug 14, 2025 | SESE |
| K251707 | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | Shenzhen Huachuangtong Industrial Co., Ltd. | Aug 1, 2025 | SESE |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. | Jul 24, 2025 | SESE |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | Shenzhen Fansizhe Science and Technology Co., Ltd. | Jul 14, 2025 | SESE |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Shenzhen Ulike Smart Electronics Co., Ltd. | Jul 11, 2025 | SESE |
| K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Jun 30, 2025 | SESE |
Top Applicants
- Shenzhen Ulike Smart Electronics Co., Ltd. — 17 clearances
- Cyden Limited — 15 clearances
- El Global Trade, Ltd. — 6 clearances
- Shenzhen Fansizhe Science and Technology Co., Ltd. — 5 clearances
- Home Skinovations , Ltd. — 4 clearances
