The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Multiyag Laser.
| Device ID | K915561 |
| 510k Number | K915561 |
| Device Name: | ZEISS MULTIYAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Christophr Talbot |
| Correspondent | Christophr Talbot CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-03-11 |