The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulas Trion Laser System With The Vite Option.
| Device ID | K103056 |
| 510k Number | K103056 |
| Device Name: | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION |
| Classification | Laser, Ophthalmic |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-15 |
| Decision Date | 2011-02-01 |
| Summary: | summary |