HJQ · Stereoscope, Ac-Powered
Ophthalmic · 21 CFR 886.1870 · Class 1
Overview
| Product Code | HJQ |
|---|---|
| Device Name | Stereoscope, Ac-Powered |
| Regulation | 21 CFR 886.1870 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Classification Rationale
Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K830625 | CYTO-STAIN | Richard-Allan Medical Ind., Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Richard-Allan Medical Ind., Inc. — 1 clearance
