The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Visumax Femtosecond Laser.
| Device ID | K173371 |
| 510k Number | K173371 |
| Device Name: | VisuMax Femtosecond Laser |
| Classification | Keratome, Ac-powered |
| Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Contact | Todd Otani |
| Correspondent | Todd Otani Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-27 |
| Decision Date | 2018-04-13 |
| Summary: | summary |