HJK · Class II · 21 CFR 886.1385

FDA Product Code HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Leading manufacturers include Ocular Instruments, Inc., Volk Optical, Inc. and Insight Instruments, Inc..

41
Total
41
Cleared
82d
Avg days
1979
Since

FDA 510(k) Cleared Lens, Contact, Polymethylmethacrylate, Diagnostic Devices (Product Code HJK)

41 devices
1–24 of 41
Cleared Sep 10, 2020
RxSight Contact Lens
K201909
Rxsight, Inc.
Ophthalmic · 63d
Cleared Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944
Phakos
Ophthalmic · 303d
Cleared Aug 18, 2015
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K151961
Volk Optical, Inc.
Ophthalmic · 33d
Cleared Dec 16, 2014
Sensor Medical Family of Vitrectomy Lenses and Products
K142715
Sensor Medical Technology, LLC
Ophthalmic · 85d
Cleared Jun 29, 2005
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630
Insight Instruments, Inc.
Ophthalmic · 12d
Cleared Jun 07, 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103
Haag-Streit USA, Inc.
Ophthalmic · 39d
Cleared Mar 28, 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K050623
Volk Optical, Inc.
Ophthalmic · 18d
Cleared Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054
Fci Ophthalmics, Inc.
Ophthalmic · 51d
Cleared Oct 11, 2002
CONTACT LASER & DIAGNOSTIC LENSES
K023221
Volk Optical, Inc.
Ophthalmic · 14d
Cleared Sep 24, 2002
LUNEAU 3 MIRROR LENS
K022413
Luneau SA
Ophthalmic · 62d
Cleared Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170
Ocular Instruments, Inc.
Ophthalmic · 74d
Cleared Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
K012096
Ocular Instruments, Inc.
Ophthalmic · 50d
Cleared Aug 06, 1997
ENDOVIEW SPPHIRE LENS SET
K971853
American Medical Devices, Inc.
Ophthalmic · 78d
Cleared Nov 08, 1994
MANDELKORN SUTURE LYSIS LENS
K933976
Ocular Instruments, Inc.
Ophthalmic · 452d
Cleared Oct 31, 1994
RITCH NYLON SUTURE LASER LENS
K933264
Ocular Instruments, Inc.
Ophthalmic · 482d
Cleared Aug 29, 1994
50 DEGREE HRI PRISM LENS
K941420
Ocular Instruments, Inc.
Ophthalmic · 159d
Cleared Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
K914051
Ocular Instruments, Inc.
Ophthalmic · 90d
Cleared Nov 13, 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K914117
Ocular Instruments, Inc.
Ophthalmic · 61d
Cleared Jun 25, 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
K912366
Ocular Instruments, Inc.
Ophthalmic · 27d
Cleared Jan 28, 1991
NMR-K FUNDUS LASER LENS
K910231
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Dec 18, 1989
MAINSTER WIDE FIELD LASER LENS
K896198
Ocular Instruments, Inc.
Ophthalmic · 52d
Cleared Oct 04, 1989
WOLDOFF PRISMATIC BICONCAVE LENS
K894421
Ocular Instruments, Inc.
Ophthalmic · 79d
Cleared Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 26, 1988
BICONCAVE VITRECTOMY LENS
K875331
Ocular Instruments, Inc.
Ophthalmic · 58d

About Product Code HJK - Regulatory Context