← Product Code [HKW](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKW) · K911374

# PLASTIC OVERLAYS (K911374)

_National Reading Service · HKW · Jul 26, 1991 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKW/K911374

## Device Facts

- **Applicant:** National Reading Service
- **Product Code:** [HKW](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKW.md)
- **Decision Date:** Jul 26, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1650
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKW/K911374](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKW/K911374)

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