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/submissions/OP/subpart-e%E2%80%94surgical-devices/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 315) Showing 20 most recent of 315 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252052](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K252052.md) | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Mar 25, 2026 | SESE | | [K250501](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K250501.md) | System Sophi | This AG | Nov 14, 2025 | SESE | | [K243395](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K243395.md) | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 8, 2025 | SESE | | [K242801](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K240169.md) | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | Jul 26, 2024 | SESE | | [K233398](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233398.md) | Faros Surgical System | Oertli Instrumente AG | Jun 27, 2024 | SESE | | [K233876](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233876.md) | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | Jun 21, 2024 | SESE | | [K232084](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K232084.md) | Stellaris Elite vision enhancement system | Bausch and Lomb | Feb 26, 2024 | SESE | | [K233902](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233902.md) | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | Jan 10, 2024 | SESE | | [K230858](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K230858.md) | QUATERA 700 | Carl Zeiss Meditec, AG | Jul 31, 2023 | SESE | | [K214028](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K214028.md) | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Sep 9, 2022 | SESE | | [K222236](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K222236.md) | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 24, 2022 | SESE | | [K213467](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K213467.md) | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | Jun 14, 2022 | SESE | | [K212241](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K212241.md) | QUATERA 700 | Carl Zeiss Meditec, AG | Apr 19, 2022 | SESE | | [K203060](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K200207.md) | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Oct 15, 2020 | SESE | | [K200584](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K200584.md) | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Jul 31, 2020 | SESE | | [K193376](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K193376.md) | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | Jun 15, 2020 | SESE | | [K192418](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K192418.md) | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | May 27, 2020 | SESE | | [K191650](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K191650.md) | LEGION System | Alcon Research, LLC | Nov 1, 2019 | 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/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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