K200911 is an FDA 510(k) clearance for the MIRA Adapter. This device is classified as a Unit, Cryophthalmic, Ac-powered (Class II - Special Controls, product code HRN).
Submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on June 2, 2020, 57 days after receiving the submission on April 6, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K200911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2020 |
| Decision Date | June 02, 2020 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HRN - Unit, Cryophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4170 |