K040204 is an FDA 510(k) clearance for the ZYOPTIX XP MICROKERATOME. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on March 22, 2004, 53 days after receiving the submission on January 29, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K040204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2004 |
| Decision Date | March 22, 2004 |
| Days to Decision | 53 days |
| Submission Type | Special |
| 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 |