← Product Code [HRG](/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG) · K843957

# ULTRATHIN/SP LENS (K843957)

_Optical Systems Intl., Inc. · HRG · Jul 31, 1985 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K843957

## Device Facts

- **Applicant:** Optical Systems Intl., Inc.
- **Product Code:** [HRG](/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG.md)
- **Decision Date:** Jul 31, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4070
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K843957](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K843957)

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