Panels › Ophthalmic › Product code HJK · Class 2
Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation 886.1385
0510(k)s in 12 months (41 all time)
1recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in HJK
| Company | 510(k)s | Recalls |
|---|---|---|
| Ocular Instruments, Inc. | 25 | 0 |
| Volk Optical, Inc. | 4 | 2 |
| American Medical Devices, Inc. | 1 | 0 |
| Concept, Inc. | 1 | 0 |
| Dutch Ophthalmic Research Center (D.O.R.C.) | 1 | 0 |
| Fci Ophthalmics, Inc. | 1 | 0 |
| Haag-Streit USA, Inc. | 1 | 0 |
| Insight Instruments, Inc. | 1 | 0 |
| Insight International, Inc. | 1 | 0 |
| Luneau SA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2020 | K201909 | RxSight Contact Lens Rxsight, Inc. | HJK |
| Oct 25, 2018 | K173944 | Endocular Viewing Lenses and Silicone Ring Phakos, FR | HJK |
| Aug 18, 2015 | K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens Volk Optical, Inc. | HJK |
| Dec 16, 2014 | K142715 | Sensor Medical Family of Vitrectomy Lenses and Products Sensor Medical Technology, LLC | HJK |
| Jun 29, 2005 | K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET Insight Instruments, Inc. | HJK |
| Jun 7, 2005 | K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY Haag-Streit USA, Inc. | HJK |
| Mar 28, 2005 | K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D Volk Optical, Inc. | HJK |
| Feb 20, 2004 | K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES Dutch Ophthalmic Research Center (D.O.R.C.) | HJK |
| Feb 26, 2003 | K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES Fci Ophthalmics, Inc. | HJK |
| Oct 11, 2002 | K023221 | CONTACT LASER & DIAGNOSTIC LENSES Volk Optical, Inc. | HJK |
| Sep 24, 2002 | K022413 | LUNEAU 3 MIRROR LENS Luneau SA, FR | HJK |
| Mar 4, 2002 | K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS Ocular Instruments, Inc. | HJK |
| Aug 24, 2001 | K012096 | DISPOSABLE VITRECTOMY LENS Ocular Instruments, Inc. | HJK |
| Aug 6, 1997 | K971853 | ENDOVIEW SPPHIRE LENS SET American Medical Devices, Inc. | HJK |
| Nov 8, 1994 | K933976 | MANDELKORN SUTURE LYSIS LENS Ocular Instruments, Inc. | HJK |
| Oct 31, 1994 | K933264 | RITCH NYLON SUTURE LASER LENS Ocular Instruments, Inc. | HJK |
| Sep 6, 1994 | K940107 | VIRECTOMY LENS Visionary Technologies of Miami, Inc. | HJK |
| Sep 2, 1994 | K943125 | QUADRASPHERIC FUNDUS LENS Volk Optical, Inc. | HJK |
| Aug 29, 1994 | K941420 | 50 DEGREE HRI PRISM LENS Ocular Instruments, Inc. | HJK |
| Dec 9, 1991 | K914051 | PEDIATRIC VITRECTOMY LENS SET Ocular Instruments, Inc. | HJK |
| Nov 13, 1991 | K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET Ocular Instruments, Inc. | HJK |
| Jun 25, 1991 | K912366 | MAINSTER HIGH MAGNIFICATION LASER LENS Ocular Instruments, Inc. | HJK |
| Jan 28, 1991 | K910231 | NMR-K FUNDUS LASER LENS Ocular Instruments, Inc. | HJK |
| Dec 18, 1989 | K896198 | MAINSTER WIDE FIELD LASER LENS Ocular Instruments, Inc. | HJK |
| Oct 4, 1989 | K894421 | WOLDOFF PRISMATIC BICONCAVE LENS Ocular Instruments, Inc. | HJK |
| Feb 26, 1988 | K875331 | BICONCAVE VITRECTOMY LENS Ocular Instruments, Inc. | HJK |
| Feb 26, 1988 | K875330 | HOSKINS-BARKAN GONIOTOMY LENS 10MM Ocular Instruments, Inc. | HJK |
| Feb 19, 1988 | K875114 | HOSKINS-BARKAN GONIOTOMY LENS 9MM Ocular Instruments, Inc. | HJK |
| Feb 19, 1988 | K875087 | PEYMAN G. 12.12 YAG LASER LENS Ocular Instruments, Inc. | HJK |
| Sep 4, 1987 | K872855 | 18MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. | HJK |
| Jun 19, 1987 | K872136 | 12.5MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. | HJK |
| Jun 3, 1987 | K871450 | 25MM PEYMAN WIDE FIELD YAG LASER LENS Ocular Instruments, Inc. | HJK |
| Dec 15, 1986 | K864304 | YANNUZZI FUNDUS LASER LENS Ocular Instruments, Inc. | HJK |
| Dec 12, 1986 | K863911 | MAINSTER RETINA LASER LENS Ocular Instruments, Inc. | HJK |
| Nov 28, 1986 | K864418 | LANDERS INDIRECT VITRECTOMY LENS Ocular Instruments, Inc. | HJK |
| Aug 21, 1986 | K863027 | SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS Ocular Instruments, Inc. | HJK |
| Aug 21, 1986 | K862868 | ABRAHAM YAG LASER LENS Ocular Instruments, Inc. | HJK |
| Aug 21, 1986 | K862728 | HOSKINS NYLON SUTURE LASER LENS Ocular Instruments, Inc. | HJK |
| Jun 19, 1986 | K862094 | LENS-EZE Insight International, Inc. | HJK |
| Jun 19, 1986 | K861648 | WISE IRIDOTOMY-SPINCTEROTOMY LENS Ocular Instruments, Inc. | HJK |
| Feb 9, 1979 | K781960 | SURGICAL EYE SHIELD Concept, Inc. | HJK |
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