Data / Medical devices / France / Clarteis
Clarteis: FDA-registered device maker in Vallauris Alpes-Maritimes, France, 2 510(k) clearances
Clarteis is registered with the FDA (registration 3014226003) in Vallauris Alpes-Maritimes, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014226003
- Address
- 2791 chemin Saint Bernard Bat A, Vallauris Alpes-Maritimes, France, 06220
- Owner or operator
- CLARTEIS (10056967)
- Roles
- Manufacturer
- First device listed
- February 5, 2018
- Registered through
- 2026
- Brand names listed
- Exci308, Exci308 by aerolase, Exciplex, Exciplex 308nm
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2019 | K191086 | Exciplex | FTC | Substantially Equivalent | Clarteis | accessdata.fda.gov |
| October 13, 2017 | K171702 | Exciplex308nm | FTC | Substantially Equivalent | Clarteis | accessdata.fda.gov |
Compare with other makers
Updated December 11, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.