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HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
HJK
Device Class
Class II
Regulation Number
886.1385
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201909rxsightRxSight Contact LensSeptember 10, 2020
K173944phakosEndocular Viewing Lenses and Silicone RingOctober 25, 2018
K151961volk opticalVolk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensAugust 18, 2015
K142715sensor medical technologySensor Medical Family of Vitrectomy Lenses and ProductsDecember 16, 2014
K051630insight instrumentsSUPER VIEW DISPOSABLE BIOM LENS SETJune 29, 2005
K051103haag-streit usaHAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORYJune 7, 2005
K050623volk opticalVOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK March 28, 2005
K033950dutch ophthalmic research center (d.o.r.c.)DORC VITRECTOMY LENSES, MODEL 1284 SERIESFebruary 20, 2004
K030054fci ophthalmicsDISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFebruary 26, 2003
K023221volk opticalCONTACT LASER & DIAGNOSTIC LENSESOctober 11, 2002
K022413luneauLUNEAU 3 MIRROR LENSSeptember 24, 2002
K014170ocular instrumentsSTAURENGHI WIDE FIELD SCANNING LASER LENSMarch 4, 2002
K012096ocular instrumentsDISPOSABLE VITRECTOMY LENSAugust 24, 2001
K971853american medical devicesENDOVIEW SPPHIRE LENS SETAugust 6, 1997
K933976ocular instrumentsMANDELKORN SUTURE LYSIS LENSNovember 8, 1994
K933264ocular instrumentsRITCH NYLON SUTURE LASER LENSOctober 31, 1994
K940107visionary technologies of miamiVIRECTOMY LENSSeptember 6, 1994
K943125volk opticalQUADRASPHERIC FUNDUS LENSSeptember 2, 1994
K941420ocular instruments50 DEGREE HRI PRISM LENSAugust 29, 1994
K914051ocular instrumentsPEDIATRIC VITRECTOMY LENS SETDecember 9, 1991