HQC · Unit, Phacofragmentation
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | HQC |
|---|---|
| Device Name | Unit, Phacofragmentation |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 315)
Showing 20 most recent of 315 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Mar 25, 2026 | SESE |
| K250501 | System Sophi | This AG | Nov 14, 2025 | SESE |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 8, 2025 | SESE |
| K242801 | 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 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | Jul 26, 2024 | SESE |
| K233398 | Faros Surgical System | Oertli Instrumente AG | Jun 27, 2024 | SESE |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | Jun 21, 2024 | SESE |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | Feb 26, 2024 | SESE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. | Jan 10, 2024 | SESE |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | Jul 31, 2023 | SESE |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Sep 9, 2022 | SESE |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 24, 2022 | SESE |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | Jun 14, 2022 | SESE |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | Apr 19, 2022 | SESE |
| K203060 | 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 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Oct 15, 2020 | SESE |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Jul 31, 2020 | SESE |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | Jun 15, 2020 | SESE |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | May 27, 2020 | SESE |
| K191650 | LEGION System | Alcon Research, LLC | Nov 1, 2019 | SESE |
Top Applicants
- Storz Instrument Co. — 17 clearances
- CooperVision, Inc. — 15 clearances
- Chiron Vision Corp. — 15 clearances
- Site Microsurgical Systems, Inc. — 14 clearances
- Abbott Medical Optics, Inc. — 9 clearances
