The following data is part of a premarket notification filed by Cyden Limited with the FDA for Venus Silk.expert.
| Device ID | K170734 |
| 510k Number | K170734 |
| Device Name: | Venus Silk.expert |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cyden Limited Technium 2, Kings Road, The Docks Swansea, GB Sa1 8pj |
| Contact | Mike Kiernan |
| Correspondent | Mike Kiernan Cyden Limited Technium 2, Kings Road, The Docks Swansea, GB Sa1 8pj |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-05-08 |