HRG · Engine, Trephine, Accessories, Ac-Powered
Ophthalmic · 21 CFR 886.4070 · Class 1
Overview
| Product Code | HRG |
|---|---|
| Device Name | Engine, Trephine, Accessories, 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | Dec 14, 2001 | SESE |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | Jun 23, 1998 | SESE |
| K843957 | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | Jul 31, 1985 | SESE |
| K841515 | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | Jun 5, 1984 | SESE |
| K823901 | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | Jan 17, 1983 | SESE |
| K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | Nov 5, 1979 | SESE |
Top Applicants
- Scanlan Intl., Inc. — 1 clearance
- Optical Systems Intl., Inc. — 1 clearance
- Laser Center Dev. Corp. — 1 clearance
- Intl. Ophthalmic Industries Corp. — 1 clearance
- Edward Weck, Inc. — 1 clearance
