The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Model Visulas 532s Laser With The Vite Option.
| Device ID | K100035 |
| 510k Number | K100035 |
| Device Name: | MODEL VISULAS 532S LASER WITH THE VITE OPTION |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-06 |
| Decision Date | 2010-03-17 |
| Summary: | summary |