HQS · Burr, Corneal, Ac-Powered
Ophthalmic · 21 CFR 886.4070 · Class 1
Overview
| Product Code | HQS |
|---|---|
| Device Name | Burr, Corneal, Ac-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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971078 | HYDROBRUSH (TM) KERATOME | Medjet, Inc. | Jan 23, 1998 | SESE |
Top Applicants
- Medjet, Inc. — 1 clearance
