The following data is part of a premarket notification filed by Phakos with the FDA for Phakos Disposable Retinal Cryo Probe.
| Device ID | K162756 |
| 510k Number | K162756 |
| Device Name: | PHAKOS Disposable Retinal Cryo Probe |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | PHAKOS 62 RUE KLEBER Montreuil, FR 93100 |
| Contact | Oliver Aumaitre |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC. 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B564MVCY1000 | K162756 | 000 |
| B564MVAD99NG0 | K162756 | 000 |
| B564MVAD98NG0 | K162756 | 000 |
| B564MVAD97NG0 | K162756 | 000 |
| B564MVAD96NG0 | K162756 | 000 |
| B564MVAD95NG0 | K162756 | 000 |
| B564MVAD94NG0 | K162756 | 000 |