← Product Code [HJI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI) · K897186

# LASER IMAGING WORK STATION (K897186)

_Innovision Medical, Inc. · HJI · Mar 12, 1990 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI/K897186

## Device Facts

- **Applicant:** Innovision Medical, Inc.
- **Product Code:** [HJI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI.md)
- **Decision Date:** Mar 12, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1395
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI/K897186](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI/K897186)

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