K212881 is an FDA 510(k) clearance for the Intense Pulsed Light (IPL) System, a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Fansizhe Science And Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 11, 2022, 213 days after receiving the submission on September 10, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K212881 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 2021 |
| Decision Date | April 11, 2022 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| 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. |