← Product Code [HJI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI) · K760949

# CHARLES IRRIGATING FUNDUS CONTACT LENS (K760949)

_Richard'S Medical Equip., Inc. · HJI · Nov 11, 1976 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI/K760949

## Device Facts

- **Applicant:** Richard'S Medical Equip., Inc.
- **Product Code:** [HJI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI.md)
- **Decision Date:** Nov 11, 1976
- **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/K760949](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJI/K760949)

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