K173371 is an FDA 510(k) clearance for the VisuMax Femtosecond Laser. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on April 13, 2018, 168 days after receiving the submission on October 27, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K173371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2017 |
| Decision Date | April 13, 2018 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |