Lens, Contact, Polymethylmethacrylate, Diagnostic

FDA product code HJK · 39 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1385
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-02-09 – 2020-09-10

HJK 2020-09-10

RxSight Contact Lens

Applicant Rxsight, Inc.

K number K201909

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HJK 2018-10-25

Endocular Viewing Lenses and Silicone Ring

Applicant Phakos

K number K173944

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HJK 2005-06-29

SUPER VIEW DISPOSABLE BIOM LENS SET

Applicant Insight Instruments, Inc.

K number K051630

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HJK 2005-06-07

HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY

Applicant Haag-Streit USA, Inc.

K number K051103

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HJK 2005-03-28

VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

Applicant Volk Optical, Inc.

K number K050623

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HJK 2004-02-20

DORC VITRECTOMY LENSES, MODEL 1284 SERIES

Applicant Dutch Ophthalmic Research Center (D.O.R.C.)

K number K033950

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HJK 2003-02-26

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

Applicant Fci Ophthalmics, Inc.

K number K030054

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HJK 2002-10-11

CONTACT LASER & DIAGNOSTIC LENSES

Applicant Volk Optical, Inc.

K number K023221

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HJK 2002-09-24

LUNEAU 3 MIRROR LENS

Applicant Luneau SA

K number K022413

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HJK 2002-03-04

STAURENGHI WIDE FIELD SCANNING LASER LENS

Applicant Ocular Instruments, Inc.

K number K014170

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HJK 2001-08-24

DISPOSABLE VITRECTOMY LENS

Applicant Ocular Instruments, Inc.

K number K012096

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HJK 1997-08-06

ENDOVIEW SPPHIRE LENS SET

Applicant American Medical Devices, Inc.

K number K971853

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HJK 1994-11-08

MANDELKORN SUTURE LYSIS LENS

Applicant Ocular Instruments, Inc.

K number K933976

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HJK 1994-10-31

RITCH NYLON SUTURE LASER LENS

Applicant Ocular Instruments, Inc.

K number K933264

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HJK 1994-09-06

VIRECTOMY LENS

Applicant Visionary Technologies of Miami, Inc.

K number K940107

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HJK 1994-09-02

QUADRASPHERIC FUNDUS LENS

Applicant Volk Optical, Inc.

K number K943125

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HJK 1994-08-29

50 DEGREE HRI PRISM LENS

Applicant Ocular Instruments, Inc.

K number K941420

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HJK 1991-12-09

PEDIATRIC VITRECTOMY LENS SET

Applicant Ocular Instruments, Inc.

K number K914051

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HJK 1991-11-13

LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET

Applicant Ocular Instruments, Inc.

K number K914117

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HJK 1991-06-25

MAINSTER HIGH MAGNIFICATION LASER LENS

Applicant Ocular Instruments, Inc.

K number K912366

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HJK 1991-01-28

NMR-K FUNDUS LASER LENS

Applicant Ocular Instruments, Inc.

K number K910231

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HJK 1989-12-18

MAINSTER WIDE FIELD LASER LENS

Applicant Ocular Instruments, Inc.

K number K896198

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HJK 1989-10-04

WOLDOFF PRISMATIC BICONCAVE LENS

Applicant Ocular Instruments, Inc.

K number K894421

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HJK 1988-02-26

BICONCAVE VITRECTOMY LENS

Applicant Ocular Instruments, Inc.

K number K875331

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HJK 1988-02-26

HOSKINS-BARKAN GONIOTOMY LENS 10MM

Applicant Ocular Instruments, Inc.

K number K875330

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HJK 1988-02-19

HOSKINS-BARKAN GONIOTOMY LENS 9MM

Applicant Ocular Instruments, Inc.

K number K875114

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HJK 1988-02-19

PEYMAN G. 12.12 YAG LASER LENS

Applicant Ocular Instruments, Inc.

K number K875087

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HJK 1987-09-04

18MM PEYMAN WIDE FIELD YAG LASER LENS

Applicant Ocular Instruments, Inc.

K number K872855

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HJK 1987-06-19

12.5MM PEYMAN WIDE FIELD YAG LASER LENS

Applicant Ocular Instruments, Inc.

K number K872136

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HJK 1987-06-03

25MM PEYMAN WIDE FIELD YAG LASER LENS

Applicant Ocular Instruments, Inc.

K number K871450

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HJK 1986-12-15

YANNUZZI FUNDUS LASER LENS

Applicant Ocular Instruments, Inc.

K number K864304

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HJK 1986-12-12

MAINSTER RETINA LASER LENS

Applicant Ocular Instruments, Inc.

K number K863911

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HJK 1986-11-28

LANDERS INDIRECT VITRECTOMY LENS

Applicant Ocular Instruments, Inc.

K number K864418

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HJK 1986-08-21

SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS

Applicant Ocular Instruments, Inc.

K number K863027

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HJK 1986-08-21

ABRAHAM YAG LASER LENS

Applicant Ocular Instruments, Inc.

K number K862868

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HJK 1986-08-21

HOSKINS NYLON SUTURE LASER LENS

Applicant Ocular Instruments, Inc.

K number K862728

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HJK 1986-06-19

LENS-EZE

Applicant Insight International, Inc.

K number K862094

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HJK 1986-06-19

WISE IRIDOTOMY-SPINCTEROTOMY LENS

Applicant Ocular Instruments, Inc.

K number K861648

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HJK 1979-02-09

SURGICAL EYE SHIELD

Applicant Concept, Inc.

K number K781960

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