← Product Code [NCF](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF) · K000637

# CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637)

_Alcon Laboratories, Inc. · NCF · May 19, 2000 · Ophthalmic · SESU_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K000637

## Device Facts

- **Applicant:** Alcon Laboratories, Inc.
- **Product Code:** [NCF](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF.md)
- **Decision Date:** May 19, 2000
- **Decision:** SESU
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1760
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K000637](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NCF/K000637)

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