MXO · Laser, System, Phacolysis
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | MXO |
|---|---|
| Device Name | Laser, System, Phacolysis |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.
