21 CFR 886.4070 — Engine, Trephine, Accessories, Gas-Powered
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4070
Identification
A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HLD | Engine, Trephine, Accessories, Gas-Powered | 1 | 0 | |
| HOG | Burr, Corneal, Battery-Powered | 1 | 5 | |
| HQS | Burr, Corneal, Ac-Powered | 1 | 1 | |
| HRF | Engine, Trephine, Accessories, Battery-Powered | 1 | 0 | |
| HRG | Engine, Trephine, Accessories, Ac-Powered | 1 | 6 | |
| OHW | Burr, Corneal, Battery Powered, Rust Ring Removal | 1 | 0 | |
| OHX | Burr, Corneal, Ac-Powered, Rust Ring Removal | 1 | 0 |
