FDA Product Code
FDA Product Code HJK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1385
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201909 | RxSight Contact Lens | Rxsight, Inc. | 2020-09-10 | Traditional | PDF ↗ |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018-10-25 | Traditional | PDF ↗ |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | 2015-08-18 | Special | PDF ↗ |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | 2014-12-16 | Traditional | PDF ↗ |
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | 2005-06-29 | Traditional | PDF ↗ |
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | 2005-06-07 | Traditional | PDF ↗ |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | Volk Optical, Inc. | 2005-03-28 | Special | PDF ↗ |
| K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | Dutch Ophthalmic Research Center (D.O.R.C.) | 2004-02-20 | Traditional | PDF ↗ |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Fci Ophthalmics, Inc. | 2003-02-26 | Traditional | PDF ↗ |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | 2002-10-11 | Special | PDF ↗ |
| K022413 | LUNEAU 3 MIRROR LENS | Luneau SA | 2002-09-24 | Traditional | PDF ↗ |
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | 2002-03-04 | Traditional | PDF ↗ |
| K012096 | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | 2001-08-24 | Traditional | PDF ↗ |
| K971853 | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K933976 | MANDELKORN SUTURE LYSIS LENS | Ocular Instruments, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K933264 | RITCH NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | 1994-10-31 | Traditional | PDF ↗ |
| K940107 | VIRECTOMY LENS | Visionary Technologies of Miami, Inc. | 1994-09-06 | Traditional | PDF ↗ |
| K943125 | QUADRASPHERIC FUNDUS LENS | Volk Optical, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K941420 | 50 DEGREE HRI PRISM LENS | Ocular Instruments, Inc. | 1994-08-29 | Traditional | PDF ↗ |
| K914051 | PEDIATRIC VITRECTOMY LENS SET | Ocular Instruments, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET | Ocular Instruments, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K912366 | MAINSTER HIGH MAGNIFICATION LASER LENS | Ocular Instruments, Inc. | 1991-06-25 | Traditional | PDF ↗ |
| K910231 | NMR-K FUNDUS LASER LENS | Ocular Instruments, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K896198 | MAINSTER WIDE FIELD LASER LENS | Ocular Instruments, Inc. | 1989-12-18 | Traditional | PDF ↗ |
| K894421 | WOLDOFF PRISMATIC BICONCAVE LENS | Ocular Instruments, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K875330 | HOSKINS-BARKAN GONIOTOMY LENS 10MM | Ocular Instruments, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K875331 | BICONCAVE VITRECTOMY LENS | Ocular Instruments, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K875114 | HOSKINS-BARKAN GONIOTOMY LENS 9MM | Ocular Instruments, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K875087 | PEYMAN G. 12.12 YAG LASER LENS | Ocular Instruments, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K872855 | 18MM PEYMAN WIDE FIELD YAG LASER LENS | Ocular Instruments, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K872136 | 12.5MM PEYMAN WIDE FIELD YAG LASER LENS | Ocular Instruments, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K871450 | 25MM PEYMAN WIDE FIELD YAG LASER LENS | Ocular Instruments, Inc. | 1987-06-03 | Traditional | PDF ↗ |
| K864304 | YANNUZZI FUNDUS LASER LENS | Ocular Instruments, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K863911 | MAINSTER RETINA LASER LENS | Ocular Instruments, Inc. | 1986-12-12 | Traditional | PDF ↗ |
| K864418 | LANDERS INDIRECT VITRECTOMY LENS | Ocular Instruments, Inc. | 1986-11-28 | Traditional | PDF ↗ |
| K862728 | HOSKINS NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K863027 | SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS | Ocular Instruments, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K862868 | ABRAHAM YAG LASER LENS | Ocular Instruments, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K861648 | WISE IRIDOTOMY-SPINCTEROTOMY LENS | Ocular Instruments, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K862094 | LENS-EZE | Insight International, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K781960 | SURGICAL EYE SHIELD | Concept, Inc. | 1979-02-09 | Traditional | PDF ↗ |
Product code HJK · Class II · Ophthalmic. Data: openFDA.