K113696 is an FDA 510(k) clearance for the OPTOS ADVANCE. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Optos Plc. (Washington, US). The FDA issued a Cleared decision on May 25, 2012, 161 days after receiving the submission on December 16, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K113696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2011 |
| Decision Date | May 25, 2012 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ - System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |