← Product Code [HJX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJX) · K000544

# BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544)

_Labtician Ophthalmics, Inc. · HJX · Mar 9, 2000 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJX/K000544

## Device Facts

- **Applicant:** Labtician Ophthalmics, Inc.
- **Product Code:** [HJX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJX.md)
- **Decision Date:** Mar 9, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5810
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJX/K000544](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJX/K000544)

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