← Product Code [HJB](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB) · K864037

# KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (K864037)

_Kera Corp. · HJB · Nov 13, 1986 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K864037

## Device Facts

- **Applicant:** Kera Corp.
- **Product Code:** [HJB](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB.md)
- **Decision Date:** Nov 13, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1450
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K864037](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K864037)

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