21 CFR 886.4670 — Unit, Phacofragmentation
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4670
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 315 | 3rd Party |
| MUS | Fluidic, Phacoemulsification/Phacofragmentation | 2 | 1 | 3rd Party |
| MXO | Laser, System, Phacolysis | 2 | 0 | 3rd Party |
| NKX | Needle, Phacoemulsification, Reprocessed | 2 | 5 | 3rd Party |
| QDW | Phaco Kit | 2 | 0 |
