PLASTIC OVERLAYS
Device Facts
| Record ID | K911374 |
|---|---|
| Device Name | PLASTIC OVERLAYS |
| Applicant | National Reading Service |
| Product Code | HKW · Ophthalmic |
| Decision Date | Jul 26, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1650 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.
