K201325 is an FDA 510(k) clearance for the Optomed Smartscope M5 with Optomed Smartscope FA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Optomed Oyj (Oulu, FI). The FDA issued a Cleared decision on November 20, 2020, 186 days after receiving the submission on May 18, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K201325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2020 |
| Decision Date | November 20, 2020 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI - Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |