MUS · Fluidic, Phacoemulsification/Phacofragmentation
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | MUS |
|---|---|
| Device Name | Fluidic, Phacoemulsification/Phacofragmentation |
| 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 (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K980292 | CATARACT LIQUEFRACTURE DEVICE | Alcon Laboratories | May 19, 1998 | SESE |
Top Applicants
- Alcon Laboratories — 1 clearance
