← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K831701

# UNIVERSAL PACK (K831701)

_Atlantic Optical Systems, Inc. · HQC · Jul 12, 1983 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K831701

## Device Facts

- **Applicant:** Atlantic Optical Systems, Inc.
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** Jul 12, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4670
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K831701](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K831701)

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