K081681 is an FDA 510(k) clearance for the VITRECTOMY CUTTER AND ACCESSORIES. This device is classified as a Vitrectomy, Instrument Cutter (Class II - Special Controls, product code MLZ).
Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 8, 2008, 113 days after receiving the submission on June 17, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K081681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2008 |
| Decision Date | October 08, 2008 |
| Days to Decision | 113 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MLZ — Vitrectomy, Instrument Cutter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |