← Product Code [HLZ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ) · K926540

# SOPHER AND BIERER OVUM FORCEPS (K926540)

_Thomasville Medical Assoc. · HLZ · Feb 25, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K926540

## Device Facts

- **Applicant:** Thomasville Medical Assoc.
- **Product Code:** [HLZ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ.md)
- **Decision Date:** Feb 25, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1220
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K926540](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLZ/K926540)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com