K062465 is an FDA 510(k) clearance for the ZYOPTIX XP EPI SEPARATOR SYSTEM. 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 September 6, 2006, 13 days after receiving the submission on August 24, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K062465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2006 |
| Decision Date | September 06, 2006 |
| Days to Decision | 13 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 |