K142897 is an FDA 510(k) clearance for the P200DTx. This device is classified as a Ophthalmoscope, Laser, Scanning (Class II - Special Controls, product code MYC).
Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on January 16, 2015, 105 days after receiving the submission on October 3, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K142897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2014 |
| Decision Date | January 16, 2015 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| 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 |