The following data is part of a premarket notification filed by Clarteis with the FDA for Exciplex308nm.
| Device ID | K171702 |
| 510k Number | K171702 |
| Device Name: | Exciplex308nm |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Clarteis WTC2, 120 Route Des Macarons Valbonne, FR 06 560 |
| Contact | Laurent Meilhac |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-08 |
| Decision Date | 2017-10-13 |
| Summary: | summary |