Biomicroscope, Slit-Lamp, Ac-Powered
FDA product code HJO · Class II (moderate risk) · 21 CFR 886.1850 · Ophthalmic
108510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Carl Zeiss Meditec, AG 9
- Carl Zeiss, Inc. 4
- Bausch & Lomb, Inc. 4
- R.H. Burton Co. 4
- Takagi Seiko Co., Ltd. 3
- Kowa Co. , Ltd. 3
- Keeler Limited 3
- Haag-Streit AG 3
- Reichert, Inc. 3
- Kowa Optimed, Inc. 3
- Tomey Corporation USA 2
- Suzhou 66 Vision Tech Co., Ltd. 2
- Neitz Instruments Company, Ltd. 2
- Us Ophthalmic, LLC 2
- Keeler Instruments, Inc. 2
- Woodlyn, Inc. 2
- Rightmedical Products, LLC 2
- Huvitz Co., Ltd. 2
- Shanghai Mediworks Precision Instruments Co. , Ltd. 2
- Optek Medico Co., Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | Nidek Co., Ltd. | 05/19/2017SE |
| K162636 | Marco Ultra M3, Marco Ultra M4HJO · Traditional | Takagi Seiko Co., Ltd. | 04/14/2017SE |
| K170171 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 04/06/2017SE |
| K161607 | VisuluxHJO · Traditional | Carl Zeiss Meditec, AG | 02/23/2017SE |
| K161764 | SLIT LAMP, Model: YF-100HJO · Traditional | Chongqing Yeasn Science-Technology Co., Ltd. | 02/16/2017SE |
| K161972 | Slit Lamp SL-D301HJO · Traditional | Topcon Corporation | 12/09/2016SE |
| K160327 | Aladdin HW3.0HJO · Traditional | Visia Imaging S.R.L. | 10/05/2016SE |
| K153545 | Portable Slit LampHJO · Traditional | Shanghai Bolan Optical-Electric Co., Ltd. | 06/22/2016SE |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscopeHJO · Traditional | Takagi Seiko Co., Ltd. | 05/26/2016SE |
| K152429 | Slit Lamp MicroscopeHJO · Traditional | Shanghai Mediworks Precision Instruments Co.… | 05/11/2016SE |
| K151394 | Keeler Slit LampHJO · Traditional | Keeler Limited | 09/10/2015SE |
| K143275 | IOLMaster700HJO · Traditional | Carl Zeiss Meditec, Inc. | 07/10/2015SE |
| K141954 | Xcel 455 Slit LampHJO · Special | Reichert, Inc. | 10/15/2014SE |
| K141068 | Zeiss Cataract Suite MarkerlessHJO · Traditional | Carl Zeiss Meditec, AG | 09/09/2014SE |
| K133667 | Slit Lamp SL-D701HJO · Traditional | Topcon Corp. | 08/26/2014SE |
| K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…HJO · Traditional | Keeler Limited | 07/11/2014SE |
| K133062 | Discovery SystemHJO · Traditional | Innovative Visual Systems | 06/20/2014SE |
| K133132 | Optical Biometer Al-ScanHJO · Traditional | Nidek Co., Ltd. | 06/11/2014SE |
| K131567 | AladdinHJO · Traditional | Visia Imaging S.R.L. | 06/05/2014SE |
| K131711 | YZ3 Portable Slit LampHJO · Traditional | Suzhou 66 Vision Tech Co., Ltd. | 05/09/2014SE |
| K133755 | Kowa SL-17HJO · Traditional | Kowa Co. , Ltd. | 03/11/2014SE |
| K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging SolutionHJO · Traditional | Carl Zeiss Meditec, AG | 02/12/2014SE |
| K131589 | Keeler Slit Lamp H-SeriesHJO · Abbreviated | Keeler, Ltd. | 06/27/2013SE |
| K122418 | Iolmaster 500HJO · Traditional | Carl Zeiss Meditec, AG | 04/12/2013SE |
| K110129 | Righton Zoom Slit Lamp Microscope with Photo OptionHJO · Traditional | Rightmedical Products, LLC | 08/30/2011SE |
| K110489 | Slit Lamp SL-2GHJO · Traditional | Topcon Medical Systems, Inc. | 05/23/2011SE |
| K101182 | Iolmaster 500HJO · Traditional | Carl Zeiss Meditec, AG | 11/03/2010SE |
| K100439 | Mediworks Slit LampHJO · Traditional | Shanghai Mediworks Precision Instruments Co.… | 07/16/2010SE |
| K100202 | Slit Lamp Bo 900, BQ 900, BP900HJO · Traditional | Haag-Streit AG | 03/19/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | Keeler Instruments, Inc. | 03/09/2010SE |
| K093021 | Atlantis Slit LampHJO · Traditional | Us Opthalmic, LLC | 01/28/2010SE |
| K092883 | LED Lamp or OtherHJO · Traditional | Intravista Medical Systems, Inc. | 12/18/2009SE |
| K093639 | Slit Lamp, Models HS-5000, HS-5500 and HS-7500HJO · Traditional | Huvitz Co., Ltd. | 12/03/2009SE |
| K082891 | Lenstar, Model LS900HJO · Traditional | Haag-Streit AG | 10/20/2009SE |
| K080776 | Gilras Slit Lamp, Models GR-SL7, GR-SL36, GR-SL54 and GR-SL72HJO · Traditional | Us Ophthalmic, LLC | 09/09/2008SE |
| K082031 | Appasamy Slit Lamp, A1A-11 and A1A-12 SeriesHJO · Traditional | Appasamy Associates | 07/31/2008SE |
| K072861 | Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series)HJO · Traditional | Acheve Technology, Inc. | 06/24/2008SE |
| K073190 | Slit LampHJO · Traditional | Huvitz Co., Ltd. | 01/11/2008SE |
| K063352 | Ellex Slit Lamp, Model 30XLHJO · Traditional | Takagi Seiko Co., Ltd. | 03/13/2007SE |
| K063750 | Xcel 255 Slit LampHJO · Traditional | Reichert, Inc. | 12/20/2006SE |
| K063640 | Kowa SL-15HJO · Special | Kowa Co. , Ltd. | 12/18/2006SE |
| K063416 | Luxvision Slit LampHJO · Traditional | Us Ophthalmic, LLC | 12/07/2006SE |
| K061330 | PSL Portable Slit LampHJO · Abbreviated | Reichert, Inc. | 05/25/2006SE |
| K060869 | RS-1000 Zoom Slitlamp with OptionHJO · Traditional | Rightmedical Products, LLC | 05/11/2006SE |
| K043503 | Visx Customvue Slit Illuminator with Desktop Charger, Model CV SI-1HJO · Traditional | Visx, Incorporated | 04/05/2005SE |
| K033190 | Vision-Tech Yz Slit Lamp, Model 66HJO · Traditional | Suzhou 66 Vision-Tech Co., Ltd. | 12/04/2003SE |
| K012873 | Documenting Laser Slit Lamp, DP 2010HJO · Traditional | Bausch & Lomb, Inc. | 11/19/2001SE |
| K012416 | Confoscan 2 Confocal MicroscopeHJO · Traditional | Nidek Technologies Srl | 10/26/2001SE |
| K993357 | IolmasterHJO · Traditional | Carl Zeiss, Inc. | 03/20/2000SE |
| K992836 | SL990, SL980, SL950HJO · Traditional | Cso | 11/09/1999SE |
| K982057 | BC 900 Slit LampHJO · Traditional | Haag-Streit AG | 08/14/1998SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | Keeler Instruments, Inc. | 04/07/1998SE |
| K974467 | Aesculap-Meditec Slit Lamps SL07 and SL08HJO · Traditional | Aesculap-Meditec North America | 02/19/1998SE |
| K971953 | ConfoscanHJO · Traditional | Tomey Corporation USA | 08/14/1997SE |
| K970414 | Confocal MicroscopeHJO · Traditional | Con-S , Ltd. | 07/15/1997SE |
| K962532 | Rodenstock Slitlamp (Model 5000 & 4000)HJO · Traditional | Expertech Assoc., Inc. | 07/25/1996SE |
| K962522 | Model SL-YZ5EHJO · Traditional | Pacific Ophthalmic Supply | 07/25/1996SE |
| K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BHJO · Traditional | Kowa Optimed, Inc. | 11/24/1995SE |
| K945445 | Bobes Slit LampHJO · Traditional | Bobes S.A. | 10/17/1995SE |
| K953965 | 904 Slit LampHJO · Traditional | Clement Clarke, Inc. | 09/27/1995SE |
| K953030 | Slit Lamp Aia 11HJO · Traditional | Naveen Intl., Inc. | 07/12/1995SE |
| K951341 | Neitz Slit Lamp SL-H2HJO · Traditional | Neitz Instruments Company, Ltd. | 06/15/1995SE |
| K951184 | Oti Model 78-60HJO · Traditional | Oti Medical, LLC | 05/12/1995SE |
| K951340 | Neitz Slit Lamp SL-H1HJO · Traditional | Neitz Instruments Company, Ltd. | 04/10/1995SE |
| K951054 | Xcel Slit LampHJO · Traditional | Leica, Inc. | 03/22/1995SE |
| K944910 | Tomey EM-1000 Specular MicroscopeHJO · Traditional | Tomey Corporation USA | 11/22/1994SE |
| K936209 | Slit Lamp, H-201HJO · Traditional | Canon USA, Inc. | 04/01/1994SE |
| K930518 | Talia Laser SlitHJO · Traditional | Talia Technology , Ltd. | 01/25/1994SE |
| K925641 | Zeiss 20 SL Slit-Lamp & Mechanical MicromanipulatrHJO · Traditional | Carl Zeiss, Inc. | 09/09/1993SE |
| K930438 | Marco Models G,H and Primary Care Slit LampsHJO · Traditional | Marco Ophthalmic, Inc. | 08/09/1993SE |
| K924783 | Burton Slit Lamp - Model 850HJO · Traditional | R.H. Burton Co. | 04/14/1993SE |
| K924787 | Burton Slit LampHJO · Traditional | R.H. Burton Co. | 01/27/1993SE |
| K924782 | Burton Slit Lamp - Model 2000HJO · Traditional | R.H. Burton Co. | 01/27/1993SE |
| K924770 | Burton Hand Held Slit Lamp - Model SL750HJO · Traditional | R.H. Burton Co. | 01/27/1993SE |
| K915356 | OpacitracHJO · Traditional | Oculon Corp. | 02/21/1992SE |
| K913852 | Laser Flare MeterHJO · Traditional | Kowa Optimed, Inc. | 02/07/1992SE |
| K912514 | Tandem Scanning MicroscopeHJO · Traditional | Tandem Scanning Corp. | 12/16/1991SE |
| K910980 | Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional | Site Microsurgical Systems, Inc. | 05/22/1991SE |
| K900477 | Woodlyn Classic Slit Lamp Model SMMHJO · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| K900476 | Woodlyn Slit Lamp Model HR-1HJO · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| K880920 | Laser Flare Cell Meter FC-1000HJO · Traditional | Kowa Optimed, Inc. | 09/27/1988SE |
| K874160 | Zeiss 40 Sl/P Photo Slit LampHJO · Traditional | Carl Zeiss, Inc. | 01/27/1988SE |
| K874220 | Ocs 100 (Ocular Comparator System)HJO · Traditional | Ocular Instruments, Inc. | 12/23/1987SE |
| K863970 | MLC Endothelial Cell CounterHJO · Traditional | Mlc Technologies | 12/29/1986SE |
| K863048 | Opm Slit Lamp Model P-1 & Model P-3HJO · Traditional | Optek Medico Co., Ltd. | 09/03/1986SE |
| K862379 | Corneal Modeling SystemHJO · Traditional | Computed Anatomy, Inc. | 08/25/1986SE |
| K862520 | Bausch & Lomb PSL-3000 Slit LampHJO · Traditional | Bausch & Lomb, Inc. | 07/11/1986SE |
| K862516 | Bausch & Lomb OSL-2000 Slit LampHJO · Traditional | Bausch & Lomb, Inc. | 07/11/1986SE |
| K862515 | Bausch & Lomb CSL-1000 Slit LampHJO · Traditional | Bausch & Lomb, Inc. | 07/11/1986SE |
| K861854 | Opm Slit Lamp Model P-1HJO · Traditional | Optek Medico Co., Ltd. | 07/11/1986SE |
| K862004 | Zeiss 30 Sl-LHJO · Traditional | Carl Zeiss, Inc. | 06/17/1986SE |
| K842859 | Microscope Mitts Support Tray CoverHJO · Traditional | Chiron Vision Corp. | 10/05/1984SE |
| K832911 | Abbott Globe HolderHJO · Traditional | Miami Eye Technology, Inc. | 09/29/1983SE |
| K813313 | Biomicroscopy Contact LensHJO · Traditional | Design Research Assoc., Inc. | 03/01/1982SE |
| K811153 | Coherent Flourotron MasterHJO · Traditional | Lumenis, Inc. | 06/16/1981SE |
| K810403 | Keeler/Konan Specular MicroscopeHJO · Traditional | Keeler Optical Products , Ltd. | 05/13/1981SE |
| K802355 | Metricon #120 FluorophotometerHJO · Traditional | Metricon, Ltd. | 12/17/1980SE |
| K801659 | Biophtal Clinical Endothelial MicroscopeHJO · Traditional | Coburn Optical Ind., Inc. | 09/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1560-2021 Class II | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.Examination data and patient name may be mixed up when printing or generating a pdf with the interface at… | Haag-Streit USA Inc | 04/15/2021Open, Classified |
| Z-1133-2021 Class II | IOLMaster 700When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data… | Carl Zeiss Meditec AG | 12/07/2020Terminated |
| Z-0108-2019 Class II | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700…Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography… | Carl Zeiss Meditec AG | 06/25/2018Terminated |
| Z-2587-2016 Class II | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL…Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much… | Nidek Inc | 07/01/2016Terminated |
| Z-0358-2016 Class II | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended…IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong… | Carl Zeiss Meditec AG | 10/27/2015Terminated |
| Z-0357-2016 Class II | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular…IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong… | Carl Zeiss Meditec AG | 10/27/2015Terminated |
| Z-0334-2014 Class II | Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is…The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the… | Carl Zeiss Meditec, Inc. | 10/23/2013Terminated |
| Z-0333-2014 Class II | Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is…The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the… | Carl Zeiss Meditec, Inc. | 10/23/2013Terminated |