Exciplex
Light, Ultraviolet, Dermatological
Clarteis
The following data is part of a premarket notification filed by Clarteis with the FDA for Exciplex.
Pre-market Notification Details
| Device ID | K191086 |
| 510k Number | K191086 |
| Device Name: | Exciplex |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Clarteis WTC2, 120 Route Des Macarons Valbonne, FR 06560 |
| Contact | Laurent Meilhac |
| Correspondent | Lucie Dalet Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-12-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760313461017 | K191086 | 000 |
Trademark Results [Exciplex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCIPLEX 79205928 5420470 Live/Registered |
Clarteis 2017-02-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.