CORNEAL TOPOGRAPHY SYSTEM
Device Facts
| Record ID | K923435 |
|---|---|
| Device Name | CORNEAL TOPOGRAPHY SYSTEM |
| Applicant | Par Microsystems Corp. |
| Product Code | HLQ · Ophthalmic |
| Decision Date | Feb 16, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
