K111628 is an FDA 510(k) clearance for the P200T. 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 August 19, 2011, 70 days after receiving the submission on June 10, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K111628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2011 |
| Decision Date | August 19, 2011 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MYC - Ophthalmoscope, Laser, Scanning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |