The following data is part of a premarket notification filed by Phakos with the FDA for Mira Adapter.
| Device ID | K200911 |
| 510k Number | K200911 |
| Device Name: | MIRA Adapter |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | Phakos 62 Rue Kléber Montreuil, FR 93100 |
| Contact | Olivier Aumaitre |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-06-02 |