HQE · Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Ophthalmic · 21 CFR 886.4150 · Class 2
Overview
| Product Code | HQE |
|---|---|
| Device Name | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Regulation | 21 CFR 886.4150 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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.
Cleared Devices (149)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | Aug 10, 2022 | SESE |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | Sep 27, 2017 | SESE |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | Apr 29, 2016 | SESE |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | Aug 22, 2014 | SESE |
| K121675 | VERSAVIT | Synergetics, Inc. | Jun 21, 2012 | SESE |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | May 30, 2012 | SESE |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | Apr 8, 2011 | SESE |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | Nov 4, 2003 | SESE |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | Jun 17, 2003 | SESE |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | Apr 17, 2003 | SESE |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | Apr 29, 2002 | SESE |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 12, 2001 | SESE |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | Dec 10, 1999 | SESE |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN | Ophthalmic Consultants, Inc. | Nov 19, 1999 | SESE |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | Mar 3, 1999 | SESE |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | Apr 30, 1998 | SESE |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Storz Instrument Co. | Mar 23, 1998 | SESE |
| K970670 | REUSABLE VITRECTOMY PROBE | Altex Vision | May 6, 1997 | SESE |
| K970673 | DISPOSABLE VITRECTOMY PROBE | Altex Vision | May 5, 1997 | SESE |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Storz Instrument Co. | Feb 3, 1997 | SESE |
| K961738 | VIT COMMANDER SYSTEM | Scieran Technologies, Inc. | Nov 25, 1996 | SESE |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Storz Instrument Co. | Sep 18, 1996 | SESE |
| K961078 | AUTOMATED VITRECTOMY DEVICE | Promex, Inc. | Jun 14, 1996 | SESE |
| K954816 | STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX | Storz Instrument Co. | Mar 4, 1996 | SESE |
| K953576 | STORZ DP4505 VITREOUS MEMBRANE DISSECTOR | Storz Instrument Co. | Sep 14, 1995 | SESE |
| K953575 | STORZ MVS-3201 VITRECTOMY PROBE PACK | Storz Instrument Co. | Sep 14, 1995 | SESE |
| K950852 | CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) | H.S. Intl. Co., Inc. | May 19, 1995 | SESE |
| K950799 | PRO-VIT | M. Imonti and Associates Inc., | Apr 28, 1995 | SESE |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Surgical Technologies, Inc. | Apr 18, 1995 | SESE |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Surgical Technologies, Inc. | Mar 14, 1995 | SESE |
| K934600 | MICRODRIVE | Medical Instrument Development Laboratories, Inc. | Jul 27, 1994 | SESE |
| K936302 | NIDEK MODEL VT-4000, MODIFICATION | Nidek, Inc. | Jul 15, 1994 | SESE |
| K940391 | PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE | Peregrine Surgical , Ltd. | Jun 8, 1994 | SESE |
| K940746 | VIT CUTTER MODEL 94 | Visioncare Devices, Inc. | Jun 6, 1994 | SESE |
| K932669 | SUPRA-VIT(TM) | Medical Instrument Development Laboratories, Inc. | Jun 3, 1994 | SESE |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | Grieshaber & Co. | May 3, 1994 | SESE |
| K933907 | STORZ FIBEROPTIC PICK MANIPULATOR | Storz Instrument Co. | Mar 7, 1994 | SESE |
| K932668 | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER | Synergetics, Inc. | Feb 23, 1994 | SESE |
| K934204 | INTERTIP INFUSION SET | Oasis Medical, Inc. | Feb 7, 1994 | SESE |
| K933984 | STORZ FIBEROPTIC REVERSE CUTTING KNIFE | Storz Instrument Co. | Jan 25, 1994 | SESE |
| K933208 | BARE-FIBER ENDOILLUMINATOR | Surgical Technologies, Inc. | Dec 14, 1993 | SESE |
| K924353 | NIDEK MODEL VST-4000 | Nidek, Inc. | Mar 29, 1993 | SESE |
| K924222 | MID LABS, INC. VIT MATE | Medical Instrument Development Laboratories, Inc. | Jan 27, 1993 | SESE |
| K924604 | STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV | Storz Instrument Co. | Nov 27, 1992 | SESE |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | O.R. Specialties, Inc. | Aug 18, 1992 | SESE |
| K921758 | STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM | Storz Instrument Co. | Jul 16, 1992 | SESE |
| K921460 | STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS | Storz Instrument Co. | Jul 2, 1992 | SESE |
| K920718 | DISPOSABLE POSTERIOR MICROSCISSORS | Storz Instrument Co. | May 18, 1992 | SESE |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | Site Microsurgical Systems, Inc. | May 8, 1992 | SESE |
| K915745 | D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE | Storz Instrument Co. | Mar 13, 1992 | SESE |
| K913504 | STORZ MICRO CUTTER 25 GAUGE PACK | Storz | Feb 21, 1992 | SESE |
| K913261 | DWYER EYE SYSTEMS ASPIRATION UNIT | Spectracare, Inc. | Jan 30, 1992 | SESE |
| K912384 | DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE | Nidek, Inc. | Dec 24, 1991 | SESE |
| K914038 | POLLY'S CUTTER J-225 | O.R. Specialties, Inc. | Dec 9, 1991 | SESE |
| K913837 | MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM | Vision Medical, Inc. | Nov 5, 1991 | SESE |
| K914221 | KPE 220 TS, NONSTERILE | Ipax, Inc. | Oct 25, 1991 | SESE |
| K912253 | LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING | Ocular Instruments, Inc. | Aug 7, 1991 | SESE |
| K911998 | MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM | Allergan Medical Optics | Jul 26, 1991 | SESE |
| K910973 | DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE | Surgical Technologies, Inc. | Apr 26, 1991 | SESE |
| K904909 | I/A VITROPHAGE MODEL YPR 2001 | Visioncare Devices, Inc. | Jan 28, 1991 | SESE |
| K895813 | GLAUCOMA MECHANICAL TREPHINE | Trek Medical Products, Inc. | Apr 30, 1990 | SESE |
| K896943 | SITE DISPOSABLE CUTTER AND ACCESSORIES | Site Microsurgical Systems, Inc. | Mar 8, 1990 | SESE |
| K894248 | CONVERTER SYSTEM | Mira, Inc. | Feb 27, 1990 | SESE |
| K896754 | I/A HANDPIECE | Advanced Surgical Products, Inc. | Jan 11, 1990 | SESE |
| K896305 | MULTI-USE I/A HANDPIECE | Advanced Surgical Products, Inc. | Dec 18, 1989 | SESE |
| K894278 | STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS | Storz Instrument Co. | Aug 11, 1989 | SESE |
| K890195 | JAMES SURGICAL SYSTEM J1000 | O.R. Specialties, Inc. | Aug 3, 1989 | SESE |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | Mira, Inc. | May 23, 1989 | SESE |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | Advanced Surgical Products, Inc. | May 12, 1989 | SESE |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | Mentor O & O, Inc. | May 4, 1989 | SESE |
| K890300 | INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE | CooperVision, Inc. | Apr 17, 1989 | SESE |
| K890133 | OCULAR CONNECTION MACHINE(TM) | Innovision Medical, Inc. | Apr 12, 1989 | SESE |
| K890544 | SHAPIRO CUTTER | H.S. Intl. Co., Inc. | Feb 28, 1989 | SESE |
| K884556 | DREYER CURVED ENDOILLUMINATOR | Advanced Surgical Products, Inc. | Feb 28, 1989 | SESE |
| K885196 | LASER INDIRECT OPHTHALMOSCOPE (LIO) | Coherent Medical Group | Jan 11, 1989 | SESE |
| K884043 | GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE | Grieshaber & Co. | Nov 16, 1988 | SESE |
| K883926 | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. | Site Microsurgical Systems, Inc. | Nov 15, 1988 | SESE |
| K883975 | DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. | Site Microsurgical Systems, Inc. | Oct 25, 1988 | SESE |
| K883605 | MODIFIED REUSABLE SITE FIBER OPTIC CABLE | Site Microsurgical Systems, Inc. | Oct 25, 1988 | SESE |
| K881519 | VAC-G (GUILLOTINE VITRECTOR) | B&B Medical Assoc., Inc. | Sep 8, 1988 | SESE |
| K881520 | VAC (OSCILLATING VITRECTOR) | B&B Medical Assoc., Inc. | Sep 7, 1988 | SESE |
| K880943 | MICROLINE CAT #100 | Microline Pentax, Inc. | May 26, 1988 | SESE |
| K881927 | PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES | Advanced Surgical Products, Inc. | May 25, 1988 | SESE |
| K880929 | NIDEK CV-4000 | Nidek, Inc. | May 25, 1988 | SESE |
| K880968 | MODEL 2001 PHACOEMULSIFIER ASPIRATOR | Mcghan Instrumed Corp. | Apr 19, 1988 | SESE |
| K872312 | MODEL 3000 OPHTHALMIC SURGICAL SYSTEM | Allergan Humphrey | Jul 15, 1987 | SESE |
| K871871 | SERIES TEN THOUSAND OCUTOME | CooperVision, Inc. | Jun 11, 1987 | SESE |
| K871375 | SITE PERISTALTIC MODULE SYSTEM | Site Microsurgical Systems, Inc. | May 7, 1987 | SESE |
| K870775 | ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE | Entravision, Inc. | Mar 26, 1987 | SESE |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Optical Micro Systems, Inc. | Feb 12, 1987 | SESE |
| K864035 | VES-10 INTRAOCULAR SCISSORS DRIVE | Trek Medical Products, Inc. | Dec 15, 1986 | SESE |
| K862943 | SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE | Site Microsurgical Systems, Inc. | Aug 21, 1986 | SESE |
| K862188 | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE | Coburn Optical Ind., Inc. | Aug 21, 1986 | SESE |
| K862343 | VACUUM HANDLE MODEL I/A - 1 | Cutler Medical Instruments | Jul 11, 1986 | SESE |
| K861565 | SERIES TEN THOUSAND COMPACT | CooperVision, Inc. | Jul 11, 1986 | SESE |
| K861380 | SERIES TEN THOUSAND MASTER | CooperVision, Inc. | Jul 11, 1986 | SESE |
| K860891 | AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE | Intra-Optics Labs. C/O Newman Assoc. | Apr 21, 1986 | SESE |
| K860014 | SYSTEMS PLUS | United Surgical Corp. | Mar 5, 1986 | SESE |
| K854871 | MICRO SURGICAL SYSTEM | Mira, Inc. | Feb 7, 1986 | SESE |
| K854868 | I/A - VFE SYSTEM II | Mira, Inc. | Feb 7, 1986 | SESE |
| K834162 | VIT PAC | American Surgical Co., Inc. | Feb 7, 1986 | SESE |
| K834160 | VITREONIC PLUS | American Surgical Co., Inc. | Feb 7, 1986 | SESE |
| K854508 | STORZ DAISY | Storz Instrument Co. | Feb 4, 1986 | SESE |
| K853430 | STORZ IAS DISPOSABLE PACK | Storz Instrument Co. | Dec 16, 1985 | SESE |
| K853961 | VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 | Visitec Co. | Dec 13, 1985 | SESE |
| K853457 | COBURN I/A SYSTEM | Coburn Optical Ind., Inc. | Oct 15, 1985 | SESE |
| K853382 | MAID MENTOR ASPIRATION/IRRIGATION DEVRO | Mentor O & O, Inc. | Oct 4, 1985 | SESE |
| K853308 | KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 | Frigitronics of Connecticut, Inc. | Oct 4, 1985 | SESE |
| K851936 | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT | Staar Surgical Co. | Aug 20, 1985 | SESE |
| K853135 | VISITEC 2 MICRON FLUID FILTER | Visitec Co. | Aug 9, 1985 | SESE |
| K852271 | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 | CooperVision, Inc. | Aug 9, 1985 | SESE |
| K851610 | COMBINED MVS SYSTEMS | Medical Instrument Development Laboratories, Inc. | Jul 22, 1985 | SESE |
| K851272 | VERSAPHAGE | Alphamedix, Inc. | Jul 5, 1985 | SESE |
| K843594 | AIRVIT MODEL 8500 | Lasermed Corp. | Apr 11, 1985 | SESE |
| K850857 | I/A HANDPIECE | Medical Instrument Development Laboratories, Inc. | Mar 29, 1985 | SESE |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | Optical Micro Systems, Inc. | Jan 22, 1985 | SESE |
| K843391 | INFUSION ASPIRATION VITRECTOMY SYS | Medical Instrument Development Laboratories, Inc. | Dec 19, 1984 | SESE |
| K842793 | MVS XII | Medical Instrument Development Laboratories, Inc. | Dec 19, 1984 | SESE |
| K844510 | OMS SCISSORS | Optical Micro Systems, Inc. | Dec 11, 1984 | SESE |
| K844374 | O.M.S. GUILLOTINE CUTTER | Optical Micro Systems, Inc. | Dec 11, 1984 | SESE |
| K842188 | MULTIPLE-LENS, SPECTACLES, CUSTOM | Gold Cadillac Co. | Dec 11, 1984 | SESE |
| K843041 | HESLIN DISPOS. TUBING SET | Innovative Surgical Products, Inc. | Nov 21, 1984 | SESE |
| K842471 | AUTOMATED INTRAOCULAR SCISSORS | Medical Instrument Development Laboratories, Inc. | Nov 21, 1984 | SESE |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | American Surgical Co., Inc. | Oct 5, 1984 | SESE |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | American Medical Optics | Oct 1, 1984 | SESE |
| K834155 | UNIVERSAL PACK | Atlantic Optical Systems, Inc. | Jun 19, 1984 | SESE |
| K834437 | KEATES IRRIGATION/ASPIRATION/VITREOUS | Frigitronics of Connecticut, Inc. | Mar 30, 1984 | SESE |
| K832703 | ARGON LASER SYS-MODEL 5000 | Cooper Medical Corp. | Jan 30, 1984 | SESE |
| K833371 | DISPOSABLE OCUTOME PROBE | CooperVision, Inc. | Jan 4, 1984 | SESE |
| K834163 | ULTRAVIT | American Surgical Co., Inc. | Dec 28, 1983 | SESE |
| K832446 | CATAREX DIAP. EXTRACAPSULAR CATARACT | Calliope Corp. | Oct 19, 1983 | SESE |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | Innovative Surgical Products, Inc. | Sep 29, 1983 | SESE |
| K831584 | BAILEY ASPIRATOR/IRRIGATOR | Medical Instrument Development Laboratories, Inc. | Aug 12, 1983 | SESE |
| K830037 | EXTENSION HANDLE FOR ACUTOME PROBE | Precision Medical Instruments, Inc. | Apr 6, 1983 | SESE |
| K830216 | DORC COMPACT MICRO SURGICAL SYSTEM | Jedmed Instrument Co. | Mar 9, 1983 | SESE |
| K822220 | COOPER VISION I/A SYSTEM III MODEL 1500 | CooperVision, Inc. | Oct 6, 1982 | SESE |
| K820933 | CILCO I/A HANDPIECE | Cilco, Inc. | Jun 14, 1982 | SESE |
| K820008 | VERSATOME I | Alphamedix, Inc. | Feb 22, 1982 | SESE |
| K820026 | VITRE CON | Medical Instrument Development Laboratories, Inc. | Feb 5, 1982 | SESE |
| K813274 | BLOOD POOL & SUBVETINAL FLUID ASPIRATOR | Optical Micro Systems, Inc. | Feb 5, 1982 | SESE |
| K812857 | CHARLES MICRO PROBE | Mid Laboratories, Inc. | Feb 5, 1982 | SESE |
| K813500 | OMS INFUSION-ASPIRATION HANDLE | Optical Micro Systems, Inc. | Feb 4, 1982 | SESE |
| K813389 | ULTRASONIC FRAGMENTOR | Fibra Sonics, Inc. | Feb 4, 1982 | SESE |
| K801850 | CHARLES PNEUMATIC INTRAOCULAR SCISSORS | Cooper Medical Devices Corp. | Sep 16, 1980 | SESE |
| K800110 | X-FLO | Contemporary Surgical Systems, Inc. | Feb 6, 1980 | SESE |
| K791212 | VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG | Precision Medical Instruments, Inc. | Aug 10, 1979 | SESE |
| K781471 | PNEUMATIC VITRECTOMY CONTROL UNIT | Helfgott Medical Instruments | Nov 8, 1978 | SESE |
| K771711 | BIOTOME | Berkeley Bio-Engineering | Sep 28, 1977 | SESE |
Top Applicants
- Storz Instrument Co. — 16 clearances
- Medical Instrument Development Laboratories, Inc. — 13 clearances
- Site Microsurgical Systems, Inc. — 7 clearances
- CooperVision, Inc. — 7 clearances
- Optical Micro Systems, Inc. — 6 clearances
