HOG · Burr, Corneal, Battery-Powered
Ophthalmic · 21 CFR 886.4070 · Class 1
Overview
| Product Code | HOG |
|---|---|
| Device Name | Burr, Corneal, Battery-Powered |
| Regulation | 21 CFR 886.4070 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962989 | AMOILS EPITHELIAL SCRUBBER | S. Percy Amoils | Jan 9, 1997 | SESE |
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | Mar 11, 1996 | SESE |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | May 2, 1995 | SESE |
| K883785 | GY-RO SAFE | Gy-Ro Industry, Inc. | Jan 5, 1989 | SESE |
| K834354 | OPHTEC RUST RING REMOVER | Jedmed Instrument Co. | Mar 19, 1984 | SESE |
Top Applicants
- S. Percy Amoils — 1 clearance
- Jedmed Instrument Co. — 1 clearance
- Gy-Ro Industry, Inc. — 1 clearance
- Alcon Laboratories, Inc. — 1 clearance
- Aaron Medical Industries — 1 clearance
