K250942 is an FDA 510(k) clearance for the 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). This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).
Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 11, 2025, 105 days after receiving the submission on March 28, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal..
| 510(k) Number | K250942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHT — Light Based Over-the-counter Hair Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal. |