← Product Code [HLR](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR) · K882618

# JEDMED/POLACK KERATOSCOPE HS/SL (K882618)

_Gamut Ent. · HLR · Jul 13, 1988 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR/K882618

## Device Facts

- **Applicant:** Gamut Ent.
- **Product Code:** [HLR](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR.md)
- **Decision Date:** Jul 13, 1988
- **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/K882618](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLR/K882618)

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