Product code HJK
- Device name
- Lens, Contact, Polymethylmethacrylate, Diagnostic
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1385
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201909 | RxSight Contact Lens | Rxsight, Inc. | 2020-09-10 |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018-10-25 |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | 2015-08-18 |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | 2014-12-16 |
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | 2005-06-29 |
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | 2005-06-07 |
| 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 |
| K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | Dutch Ophthalmic Research Center (D.O.R.C.) | 2004-02-20 |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Fci Ophthalmics, Inc. | 2003-02-26 |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | 2002-10-11 |
| K022413 | LUNEAU 3 MIRROR LENS | Luneau SA | 2002-09-24 |
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | 2002-03-04 |
| K012096 | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | 2001-08-24 |
| K971853 | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | 1997-08-06 |
| K933976 | MANDELKORN SUTURE LYSIS LENS | Ocular Instruments, Inc. | 1994-11-08 |
| K933264 | RITCH NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | 1994-10-31 |
| K940107 | VIRECTOMY LENS | Visionary Technologies of Miami, Inc. | 1994-09-06 |
| K943125 | QUADRASPHERIC FUNDUS LENS | Volk Optical, Inc. | 1994-09-02 |
| K941420 | 50 DEGREE HRI PRISM LENS | Ocular Instruments, Inc. | 1994-08-29 |
| K914051 | PEDIATRIC VITRECTOMY LENS SET | Ocular Instruments, Inc. | 1991-12-09 |
| K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET | Ocular Instruments, Inc. | 1991-11-13 |
| K912366 | MAINSTER HIGH MAGNIFICATION LASER LENS | Ocular Instruments, Inc. | 1991-06-25 |
| K910231 | NMR-K FUNDUS LASER LENS | Ocular Instruments, Inc. | 1991-01-28 |
| K896198 | MAINSTER WIDE FIELD LASER LENS | Ocular Instruments, Inc. | 1989-12-18 |
| K894421 | WOLDOFF PRISMATIC BICONCAVE LENS | Ocular Instruments, Inc. | 1989-10-04 |
| K875330 | HOSKINS-BARKAN GONIOTOMY LENS 10MM | Ocular Instruments, Inc. | 1988-02-26 |
| K875331 | BICONCAVE VITRECTOMY LENS | Ocular Instruments, Inc. | 1988-02-26 |
| K875087 | PEYMAN G. 12.12 YAG LASER LENS | Ocular Instruments, Inc. | 1988-02-19 |
| K875114 | HOSKINS-BARKAN GONIOTOMY LENS 9MM | Ocular Instruments, Inc. | 1988-02-19 |
| K872855 | 18MM PEYMAN WIDE FIELD YAG LASER LENS | Ocular Instruments, Inc. | 1987-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B564MVLV41HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV520 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV510 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV500 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV490 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV48HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV480 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV470 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV460 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV45HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV450 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV43HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV430 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV42HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV420 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV410 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV40HR0 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVAS100 | PHAKOS | PHAKOS | 2019-01-16 |
| B564MVLV400 | PHAKOS | PHAKOS | 2018-12-07 |
| 08717872004266 | Disposable Vitrectomy Lens: Flat | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004525 | Suturable vitrectomy lens ring 1284.DW till 1284.IW | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004471 | WideView Vitrectomy Lens: 30° Prism | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004440 | Disposable Vitrectomy Lens: 30° Prism | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004426 | WideView Vitrectomy Lens: 20° Prism | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004396 | WideView Vitrectomy Lens: Wide Field | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004389 | Disposable Vitrectomy Lens: Wide View | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004365 | Disposable Vitrectomy Lens: Magnifying | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004341 | WideView Vitrectomy Lens: Biconcave | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004327 | Disposable Vitrectomy Lens: Biconcave | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |
| 08717872004303 | WideView Vitrectomy Lens: Flat | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2016-09-23 |