The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Laser Indirect Ophthalmoscope.
| Device ID | K924588 |
| 510k Number | K924588 |
| Device Name: | ZEISS LASER INDIRECT OPHTHALMOSCOPE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Christopher Talbot |
| Correspondent | Christopher 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 | 1992-09-10 |
| Decision Date | 1993-07-09 |