K102492 is an FDA 510(k) clearance for the P200MAAF. 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 September 30, 2010, 30 days after receiving the submission on August 31, 2010.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K102492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2010 |
| Decision Date | September 30, 2010 |
| Days to Decision | 30 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 |