K162756 is an FDA 510(k) clearance for the PHAKOS Disposable Retinal Cryo Probe. 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 May 3, 2017, 215 days after receiving the submission on September 30, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K162756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2016 |
| Decision Date | May 03, 2017 |
| Days to Decision | 215 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 |