← Product Code [HJO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO) · K930438

# MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS (K930438)

_Marco Ophthalmic, Inc. · HJO · Aug 9, 1993 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K930438

## Device Facts

- **Applicant:** Marco Ophthalmic, Inc.
- **Product Code:** [HJO](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO.md)
- **Decision Date:** Aug 9, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1850
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

## Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K930438](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K930438)

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