← Product Code [HKO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO) · K862521

# BAUSCH & LOMB GR-3 REFRACTOR (K862521)

_Bausch & Lomb, Inc. · HKO · Jul 11, 1986 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K862521

## Device Facts

- **Applicant:** Bausch & Lomb, Inc.
- **Product Code:** [HKO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO.md)
- **Decision Date:** Jul 11, 1986
- **Decision:** SESE
- **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/HKO/K862521](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKO/K862521)

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