← Product Code [HPL](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPL) · K854383

# KERATOLUX (K854383)

_Carl Zeiss, Inc. · HPL · Nov 12, 1985 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPL/K854383

## Device Facts

- **Applicant:** Carl Zeiss, Inc.
- **Product Code:** [HPL](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPL.md)
- **Decision Date:** Nov 12, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1290
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPL/K854383](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPL/K854383)

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