OHT — Light Based Over-The-Counter Hair Removal Class II
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 |