The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse Smoothskin Gold Hair Removal Device, Venus Silk.expert.
| Device ID | K162231 |
| 510k Number | K162231 |
| Device Name: | IPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, GB Sa1 8pj |
| Contact | Mike Kiernan |
| Correspondent | Mike Kiernan CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, GB Sa1 8pj |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-08 |
| Decision Date | 2016-11-16 |