K222537 is an FDA 510(k) clearance for the IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi. This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).
Submitted by Shenzhen Ishine Technology Company Limited (Shenzhen, CN). The FDA issued a Cleared decision on October 14, 2022, 53 days after receiving the submission on August 22, 2022.
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 | K222537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2022 |
| Decision Date | October 14, 2022 |
| Days to Decision | 53 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. |