The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visumax Laser Keratome.
| Device ID | K100253 |
| 510k Number | K100253 |
| Device Name: | VISUMAX LASER KERATOME |
| Classification | Laser, Ophthalmic |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2010-07-08 |
| Summary: | summary |