The following data is part of a premarket notification filed by Quantel Medical with the FDA for Supra 577.y Laser.
| Device ID | K091581 |
| 510k Number | K091581 |
| Device Name: | SUPRA 577.Y LASER |
| Classification | Laser, Ophthalmic |
| Applicant | QUANTEL MEDICAL 21 RUE NEWTON - ZONE DU BREZET Clermont-ferrand, FR 63039 |
| Contact | Patrick Quero |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-02 |
| Decision Date | 2009-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700542625408 | K091581 | 000 |
| 03700542625392 | K091581 | 000 |
| 03700542625316 | K091581 | 000 |