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HQE — Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HQE
Device Class
Class II
Regulation Number
886.4150
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212763visioncare devicesUniVit HE, UniVit UHSAugust 10, 2022
K170183a.r.c laserCetus system, Cetus probeSeptember 27, 2017
K153168medical instrument development laboratoriesBi-Blade Vitrectomy CutterApril 29, 2016
K141065alcon researchCONSTELLATION VISION SYSTEMAugust 22, 2014
K121675synergeticsVERSAVITJune 21, 2012
K120170visioncare devicesPROCARE PLUS VITRECTOMY SYSTEMMay 30, 2012
K102222medical instrument development laboratoriesULTIMATE VIT ENHAMCER (UVE)April 8, 2011
K033390microworld medical instrumentsCOLIBRI DISPOSABLE VITRECTOMY CUTTERNovember 4, 2003
K030948howard instrumentsVMATE MODEL VMM1000June 17, 2003
K023939visioncare devicesVELOCITY ADVANTAGEApril 17, 2003
K020911medical instrument development laboratoriesMID LABS AUTONOMOUS VIT ENHANCER (AVE)April 29, 2002
K010082dutch ophthalmic usaD.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMMarch 12, 2001
K992943medical instrument development laboratoriesVIT ENHANCERDecember 10, 1999
K990292ophthalmic consultantsI/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PNovember 19, 1999
K983797dutch ophthalmic usaD.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMMarch 3, 1999
K980400peregrine surgicalPVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10April 30, 1998
K980399peregrine surgicalPEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20April 30, 1998
K980488storz instrumentSTORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMMarch 23, 1998
K970670altex visionREUSABLE VITRECTOMY PROBEMay 6, 1997
K970673altex visionDISPOSABLE VITRECTOMY PROBEMay 5, 1997