← Product Code [HLH](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLH) · K821082

# TRIAL LENS SET (K821082)

_Medical Equipment Designs, Inc. · HLH · Jun 14, 1982 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLH/K821082

## Device Facts

- **Applicant:** Medical Equipment Designs, Inc.
- **Product Code:** [HLH](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLH.md)
- **Decision Date:** Jun 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1700
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLH/K821082](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLH/K821082)

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