Burr, Corneal, Battery-Powered
A Battery-Powered Corneal Burr is an electrically powered ophthalmic instrument used to remove corneal rust rings or superficial lesions through rotary mechanical abrasion, offering more controlled and consistent tissue removal compared to manual alternatives. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HOG and is regulated under 21 CFR 886.4070, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOG
- Device Class
- FDA class 1
- Regulation Number
- 886.4070
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962989 | AMOILS EPITHELIAL SCRUBBER | Jan 09, 1997 | Substantially Equivalent | S. Percy Amoils |
| K960261 | PALLIKARIS BRUSH | Mar 11, 1996 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | May 02, 1995 | Substantially Equivalent | Aaron Medical Industries |
| K883785 | GY-RO SAFE | Jan 05, 1989 | Substantially Equivalent | Gy-Ro Industry, Inc. |
| K834354 | OPHTEC RUST RING REMOVER | Mar 19, 1984 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.