The following data is part of a premarket notification filed by Quantel Medical with the FDA for Vitra 2.
| Device ID | K191962 |
| 510k Number | K191962 |
| Device Name: | Vitra 2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quantel Medical 11 Rue Du Bois Joli-CS40015 Cournon D'auvergne-cedex, FR 63808 |
| Contact | Bruno Pages |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700542625569 | K191962 | 000 |