JEDMED/POLACK KERATOSCOPE HS/SL
Device Facts
| Record ID | K882618 |
|---|---|
| Device Name | JEDMED/POLACK KERATOSCOPE HS/SL |
| Applicant | Gamut Ent. |
| Product Code | HLR · Ophthalmic |
| Decision Date | Jul 13, 1988 |
| 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.
