K102222 is an FDA 510(k) clearance for the ULTIMATE VIT ENHAMCER (UVE). This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 8, 2011, 245 days after receiving the submission on August 6, 2010.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K102222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2010 |
| Decision Date | April 08, 2011 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |