QDW · Phaco Kit
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | QDW |
|---|---|
| Device Name | Phaco Kit |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
