ACUFEX COMPARATIVE SURGICAL KERATOMETER
Device Facts
| Record ID | K852424 |
|---|---|
| Device Name | ACUFEX COMPARATIVE SURGICAL KERATOMETER |
| Applicant | Acufex Microsurgical, Inc. |
| Product Code | HJB · Ophthalmic |
| Decision Date | Sep 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.
