K134039 is an FDA 510(k) clearance for the DAYTONA ICG (P200TICG). This device is classified as a Ophthalmoscope, Laser, Scanning (Class II - Special Controls, product code MYC).
Submitted by Optos Plc. (Washington, US). The FDA issued a Cleared decision on April 11, 2014, 101 days after receiving the submission on December 31, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K134039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2013 |
| Decision Date | April 11, 2014 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | MYC - Ophthalmoscope, Laser, Scanning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |