SmoothSkin Pure
Light Based Over-the-counter Hair Removal
CyDen Limited
The following data is part of a premarket notification filed by Cyden Limited with the FDA for Smoothskin Pure.
Pre-market Notification Details
| Device ID | K200184 |
| 510k Number | K200184 |
| Device Name: | SmoothSkin Pure |
| 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 | 2020-01-24 |
| Decision Date | 2020-02-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060352782837 | K200184 | 000 |
Trademark Results [SmoothSkin Pure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMOOTHSKIN PURE 97187572 not registered Live/Pending |
CyDen Limited 2021-12-23 |
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