← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K943379

# PHACO TIPS FOR PHACO FRAGMENTATION MACHINES (K943379)

_Oasis Medical, Inc. · HQC · Oct 11, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K943379

## Device Facts

- **Applicant:** Oasis Medical, Inc.
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** Oct 11, 1994
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K943379](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K943379)

**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