The following data is part of a premarket notification filed by Cyden Limited with the FDA for Braun Silk.expert Pro 5.
| Device ID | K190354 |
| 510k Number | K190354 |
| Device Name: | BRAUN Silk.expert Pro 5 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | CyDen Limited Block A, Bay Studios Business Park, Fabian Way Swansea, GB Sa1 8qb |
| Contact | Adam Stephens |
| Correspondent | Adam Stephens CyDen Limited Block A, Bay Studios Business Park, Fabian Way Swansea, GB Sa1 8qb |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-03-18 |