HJT · Haploscope
Ophthalmic · 21 CFR 886.1340 · Class 1
Overview
| Product Code | HJT |
|---|---|
| Device Name | Haploscope |
| Regulation | 21 CFR 886.1340 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013110 | ANISEIKONIA INSPECTOR | Optical Diagnostics, Inc. | Dec 19, 2001 | SESE |
| K012530 | AA-1 SYSTEM | Neurovision, Inc. | Aug 31, 2001 | SESE |
Top Applicants
- Neurovision, Inc. — 1 clearance
- Optical Diagnostics, Inc. — 1 clearance
