Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670) → HQC — Unit, Phacofragmentation

# HQC · Unit, Phacofragmentation

_Ophthalmic · 21 CFR 886.4670 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/HQC

## Overview

- **Product Code:** HQC
- **Device Name:** Unit, Phacofragmentation
- **Regulation:** [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (20 of 316)

Showing 20 most recent of 316 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261264](/device/K261264.md) | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack  (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ | Bausch and Lomb | May 15, 2026 | SESE |
| [K252052](/device/K252052.md) | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Mar 25, 2026 | SESE |
| [K250501](/device/K250501.md) | System Sophi | This AG | Nov 14, 2025 | SESE |
| [K243395](/device/K243395.md) | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 8, 2025 | SESE |
| [K242801](/device/K242801.md) | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | Jun 11, 2025 | SESE |
| [K240169](/device/K240169.md) | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | Jul 26, 2024 | SESE |
| [K233398](/device/K233398.md) | Faros Surgical System | Oertli Instrumente AG | Jun 27, 2024 | SESE |
| [K233876](/device/K233876.md) | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | Jun 21, 2024 | SESE |
| [K232084](/device/K232084.md) | Stellaris Elite vision enhancement system | Bausch and Lomb | Feb 26, 2024 | SESE |
| [K233902](/device/K233902.md) | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | Jan 10, 2024 | SESE |
| [K230858](/device/K230858.md) | QUATERA 700 | Carl Zeiss Meditec, AG | Jul 31, 2023 | SESE |
| [K214028](/device/K214028.md) | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Sep 9, 2022 | SESE |
| [K222236](/device/K222236.md) | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 24, 2022 | SESE |
| [K213467](/device/K213467.md) | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | Jun 14, 2022 | SESE |
| [K212241](/device/K212241.md) | QUATERA 700 | Carl Zeiss Meditec, AG | Apr 19, 2022 | SESE |
| [K203060](/device/K203060.md) | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | Johnson & Johnson Surgical Vision, Inc. | Mar 12, 2021 | SESE |
| [K200207](/device/K200207.md) | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Oct 15, 2020 | SESE |
| [K200584](/device/K200584.md) | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Jul 31, 2020 | SESE |
| [K193376](/device/K193376.md) | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | Jun 15, 2020 | SESE |
| [K192418](/device/K192418.md) | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | May 27, 2020 | SESE |

## Top Applicants

- Storz Instrument Co. — 17 clearances
- Chiron Vision Corp. — 15 clearances
- CooperVision, Inc. — 15 clearances
- Site Microsurgical Systems, Inc. — 14 clearances
- Abbott Medical Optics, Inc. — 9 clearances

---

**Source:** [https://fda.innolitics.com/productcode/HQC](https://fda.innolitics.com/productcode/HQC)

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