← Product Code [LQJ](/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ) · K912112

# PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (K912112)

_Tomey Corporation USA · LQJ · Jun 17, 1991 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K912112

## Device Facts

- **Applicant:** Tomey Corporation USA
- **Product Code:** [LQJ](/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ.md)
- **Decision Date:** Jun 17, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4390
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K912112](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LQJ/K912112)

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