← Product Code [HJK](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK) · K943125

# QUADRASPHERIC FUNDUS LENS (K943125)

_Volk Optical, Inc. · HJK · Sep 2, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K943125

## Device Facts

- **Applicant:** Volk Optical, Inc.
- **Product Code:** [HJK](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK.md)
- **Decision Date:** Sep 2, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1385
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K943125](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJK/K943125)

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