| Device Type ID | 4322 |
| Device Name | Unit, Cryophthalmic, Ac-powered |
| Regulation Description | Cryophthalmic Unit. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 4322 |
| Device | Unit, Cryophthalmic, Ac-powered |
| Product Code | HRN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cryophthalmic Unit. |
| CFR Regulation Number | 886.4170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHAKOS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 2 |