← Product Code [HLQ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLQ) · K945382

# TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382)

_Expertech Assoc., Inc. · HLQ · Jan 31, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLQ/K945382

## Device Facts

- **Applicant:** Expertech Assoc., Inc.
- **Product Code:** [HLQ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLQ.md)
- **Decision Date:** Jan 31, 1995
- **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/HLQ/K945382](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLQ/K945382)

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