← Product Code [HLR](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR) · K821080

# HAND KERATOSCOPE (K821080)

_Medical Equipment Designs, Inc. · HLR · May 24, 1982 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR/K821080

## Device Facts

- **Applicant:** Medical Equipment Designs, Inc.
- **Product Code:** [HLR](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR.md)
- **Decision Date:** May 24, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1350
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR/K821080](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR/K821080)

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