HJK · Class II · 21 CFR 886.1385

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

Leading manufacturers include Ocular Instruments, Inc., Phakos and Rxsight, 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 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 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
Cleared Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087
Ocular Instruments, Inc.
Ophthalmic · 72d
Cleared Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K875114
Ocular Instruments, Inc.
Ophthalmic · 67d
Cleared Sep 04, 1987
18MM PEYMAN WIDE FIELD YAG LASER LENS
K872855
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Jun 19, 1987
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
K872136
Ocular Instruments, Inc.
Ophthalmic · 16d
Cleared Jun 03, 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
K871450
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Dec 15, 1986
YANNUZZI FUNDUS LASER LENS
K864304
Ocular Instruments, Inc.
Ophthalmic · 45d
Cleared Dec 12, 1986
MAINSTER RETINA LASER LENS
K863911
Ocular Instruments, Inc.
Ophthalmic · 65d
Cleared Nov 28, 1986
LANDERS INDIRECT VITRECTOMY LENS
K864418
Ocular Instruments, Inc.
Ophthalmic · 18d
Cleared Aug 21, 1986
HOSKINS NYLON SUTURE LASER LENS
K862728
Ocular Instruments, Inc.
Ophthalmic · 34d

About Product Code HJK - Regulatory Context