The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Horus Laser Keratome.
| Device ID | K062314 |
| 510k Number | K062314 |
| Device Name: | HORUS LASER KERATOME |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Kent W Jones |
| Correspondent | Kent W Jones CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-12-22 |
| Summary: | summary |