K162231 is an FDA 510(k) clearance for the iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert. This device is classified as a Light Based Over-the-counter Hair Removal (Class II - Special Controls, product code OHT).
Submitted by Cyden Limited (Swansea, GB). The FDA issued a Cleared decision on November 16, 2016, 100 days after receiving the submission on August 8, 2016.
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 | K162231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2016 |
| Decision Date | November 16, 2016 |
| Days to Decision | 100 days |
| Submission Type | Special |
| 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. |