OHT — Light Based Over-The-Counter Hair Removal Class II
FDA product code OHT covers "Light Based Over-The-Counter Hair Removal", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OHT
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261325 | shenzhen ulike smart electronics co | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI | May 21, 2026 |
| K260594 | shenzhen xiazhifeng electronic co | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, | May 20, 2026 |
| K260742 | shenzhen ulike smart electronics co | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI2 | May 5, 2026 |
| K260518 | shenzhen semlamp intelligent technology co | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B | April 21, 2026 |
| K254047 | shenzhen chuangtong yigou technology co | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU0 | March 11, 2026 |
| K253666 | shenzhen mlay intelligent technology co | IPL Hair Removal Device (Models: T31A, T32A) | February 23, 2026 |
| K253881 | shenzhen fansizhe science and technology co | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033M | December 29, 2025 |
| K253754 | philips consumer lifestyle | Philips Lumea IPL | December 23, 2025 |
| K253304 | dongguan lide electric appliance co | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-2 | November 25, 2025 |
| K253035 | gu'an yeolight smart electronics co | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | November 19, 2025 |
| K252618 | alovea healthcare co. | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | November 14, 2025 |
| K252234 | shenzhen qiaochengli technology co | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA | October 14, 2025 |
| K252209 | foshan jindi electric appliance co | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM0 | October 10, 2025 |
| K251398 | shenzhen enmind technology co | IPL Hair Removal Device (IPL-001, IPL-002) | October 2, 2025 |
| K252804 | shenzhen ulike smart electronics co | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI2 | October 1, 2025 |
| K251914 | miley technology (hebei) co | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair | September 15, 2025 |
| K251176 | shenzhen mlay intelligent technology co., | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21 | August 14, 2025 |
| K251707 | shenzhen huachuangtong industrial co | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | August 1, 2025 |
| K251984 | shenzhen ulike smart electronics co | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI | July 24, 2025 |
| K251173 | shenzhen fansizhe science and technology co | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033M | July 14, 2025 |