Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) → HQE — Instrument, Vitreous Aspiration And Cutting, Ac-Powered # HQE · Instrument, Vitreous Aspiration And Cutting, Ac-Powered _Ophthalmic · 21 CFR 886.4150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE ## Overview - **Product Code:** HQE - **Device Name:** Instrument, Vitreous Aspiration And Cutting, Ac-Powered - **Regulation:** [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens. ## Classification Rationale Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Recent Cleared Devices (20 of 149) Showing 20 most recent of 149 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K212763](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K212763.md) | UniVit HE, UniVit UHS | Visioncare Devices, LLC | Aug 10, 2022 | SESE | | [K170183](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K170183.md) | Cetus system, Cetus probe | A.R.C Laser GmbH | Sep 27, 2017 | SESE | | [K153168](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K153168.md) | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | Apr 29, 2016 | SESE | | [K141065](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K141065.md) | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | Aug 22, 2014 | SESE | | [K121675](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K121675.md) | VERSAVIT | Synergetics, Inc. | Jun 21, 2012 | SESE | | [K120170](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K120170.md) | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | May 30, 2012 | SESE | | [K102222](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K102222.md) | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | Apr 8, 2011 | SESE | | [K033390](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K033390.md) | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | Nov 4, 2003 | SESE | | [K030948](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K030948.md) | VMATE MODEL VMM1000 | Howard Instruments, Inc. | Jun 17, 2003 | SESE | | [K023939](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K023939.md) | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | Apr 17, 2003 | SESE | | [K020911](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K020911.md) | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | Apr 29, 2002 | SESE | | [K010082](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K010082.md) | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 12, 2001 | SESE | | [K992943](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K992943.md) | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | Dec 10, 1999 | SESE | | [K990292](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K990292.md) | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | Nov 19, 1999 | SESE | | [K983797](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K983797.md) | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 3, 1999 | SESE | | [K980400](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K980400.md) | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE | | [K980399](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K980399.md) | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE | | [K980488](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K980488.md) | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Storz Instrument Co. | Mar 23, 1998 | SESE | | [K970670](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K970670.md) | REUSABLE VITRECTOMY PROBE | Altex Vision | May 6, 1997 | SESE | | [K970673](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K970673.md) | DISPOSABLE VITRECTOMY PROBE | Altex Vision | May 5, 1997 | SESE | ## Top Applicants - Storz Instrument Co. — 16 clearances - Medical Instrument Development Laboratories, Inc. — 13 clearances - CooperVision, Inc. — 7 clearances - Site Microsurgical Systems, Inc. — 7 clearances - Optical Micro Systems, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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