21 CFR 886.4390 — Laser, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4390
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | 2 | 180 | 3rd Party |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 2 | 13 | 3rd Party |
| OOE | Ophthalmic Femtosecond Laser | 2 | 47 |
