← Product Code [HLM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM) · K944022

# LENSCHEK (K944022)

_Leica, Inc. · HLM · Nov 17, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K944022

## Device Facts

- **Applicant:** Leica, Inc.
- **Product Code:** [HLM](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM.md)
- **Decision Date:** Nov 17, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1425
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K944022](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLM/K944022)

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