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 |