K062252 is an FDA 510(k) clearance for the MOLTENO3. This device is classified as a Implant, Eye Valve (Class II - Special Controls, product code KYF).
Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on September 27, 2006, 55 days after receiving the submission on August 3, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3920.
| 510(k) Number | K062252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2006 |
| Decision Date | September 27, 2006 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYF — Implant, Eye Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3920 |