CYTO-STAIN
Device Facts
| Record ID | K830625 |
|---|---|
| Device Name | CYTO-STAIN |
| Applicant | Richard-Allan Medical Ind., Inc. |
| Product Code | HJQ · Ophthalmic |
| Decision Date | Mar 24, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1870 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.