ULTRATHIN/SP LENS
Device Facts
| Record ID | K843957 |
|---|---|
| Device Name | ULTRATHIN/SP LENS |
| Applicant | Optical Systems Intl., Inc. |
| Product Code | HRG · Ophthalmic |
| Decision Date | Jul 31, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4070 |
| Device Class | Class 1 |
Regulatory Classification
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.