← Product Code [HJB](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB) · K852424

# ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424)

_Acufex Microsurgical, Inc. · HJB · Sep 11, 1985 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K852424

## Device Facts

- **Applicant:** Acufex Microsurgical, Inc.
- **Product Code:** [HJB](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB.md)
- **Decision Date:** Sep 11, 1985
- **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/K852424](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K852424)

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