K232845 is an FDA 510(k) clearance for the IPL Cooling Hair Removal Device, a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Siken 3D Technology Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 14, 2023, 61 days after receiving the submission on September 14, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K232845 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 14, 2023 |
| Decision Date | November 14, 2023 |
| Days to Decision | 61 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. |