FDA 510(k) Applications for Medical Device Product Code "HJO"
(Biomicroscope, Slit-Lamp, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072861 | ACHEVE TECHNOLOGY, INC. | CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) | 06/24/2008 |
| K974467 | AESCULAP-MEDITEC NORTH AMERICA | AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 | 02/19/1998 |
| K082031 | APPASAMY ASSOCIATES | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | 07/31/2008 |
| K012873 | BAUSCH & LOMB, INC. | DOCUMENTING LASER SLIT LAMP, DP 2010 | 11/19/2001 |
| K101182 | CARL ZEISS MEDITEC AG | IOLMASTER 500 | 11/03/2010 |
| K122418 | CARL ZEISS MEDITEC AG | IOLMASTER 500 | 04/12/2013 |
| K170171 | Carl Zeiss Meditec AG | IOLMaster 700 | 04/06/2017 |
| K173771 | Carl Zeiss Meditec AG | IOLMaster 700 | 08/24/2018 |
| K162684 | Carl Zeiss Meditec AG | SL 220 | 05/31/2017 |
| K133476 | CARL ZEISS MEDITEC AG | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | 02/12/2014 |
| K161607 | CARL ZEISS MEDITEC AG | VISULUX | 02/23/2017 |
| K141068 | CARL ZEISS MEDITEC AG | ZEISS CATARACT SUITE MARKERLESS | 09/09/2014 |
| K143275 | Carl Zeiss Meditec, Inc. | IOLMaster700 | 07/10/2015 |
| K993357 | CARL ZEISS, INC. | IOLMASTER | 03/20/2000 |
| K171877 | Chongqing Kanghua Ruiming S&T Co., Ltd. | SLM-1ER, SLM-2ER, SLM-3ER | 12/21/2017 |
| K182306 | Chongqing Sunkingdom Medical Instrument Co Ltd | Sunkingdom Slit Lamp | 11/22/2018 |
| K161764 | CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD | SLIT LAMP, Model: YF-100 | 02/16/2017 |
| K970414 | CON-S LTD. | CONFOCAL MICROSCOPE | 07/15/1997 |
| K992836 | CSO | SL990, SL980, SL950 | 11/09/1999 |
| K962532 | EXPERTECH ASSOC., INC. | RODENSTOCK SLITLAMP (MODEL 5000 & 4000) | 07/25/1996 |
| K982057 | HAAG-STREIT AG | BC 900 SLIT LAMP | 08/14/1998 |
| K082891 | HAAG-STREIT AG | LENSTAR, MODEL LS900 | 10/20/2009 |
| K100202 | HAAG-STREIT AG | SLIT LAMP BO 900, BQ 900, BP900 | 03/19/2010 |
| K073190 | HUVITZ CO., LTD. | SLIT LAMP | 01/11/2008 |
| K093639 | HUVITZ CO., LTD. | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | 12/03/2009 |
| K133062 | INNOVATIVE VISUAL SYSTEMS | DISCOVERY SYSTEM | 06/20/2014 |
| K092883 | INTRAVISTA MEDICAL SYSTEMS INC | LED LAMP OR OTHER | 12/18/2009 |
| K973064 | KEELER INSTRUMENTS, INC. | KEELER TEARSCOPE-PLUS | 04/07/1998 |
| K100500 | KEELER INSTRUMENTS, INC. | PSL CLASSIC SLIT LAMP | 03/09/2010 |
| K151394 | KEELER LIMITED | Keeler Slit Lamp | 09/10/2015 |
| K140451 | KEELER LIMITED | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | 07/11/2014 |
| K131589 | KEELER LTD. | KEELER SLIT LAMP H-SERIES | 06/27/2013 |
| K063640 | KOWA CO. LTD. | KOWA SL-15 | 12/18/2006 |
| K133755 | KOWA CO. LTD. | KOWA SL-17 | 03/11/2014 |
| K222372 | Kowa Company, Ltd. | Kowa SL-19 | 11/21/2022 |
| K170470 | Medimaging Integrated Solution Inc. (MiiS) | Digital Eye Anterior Camera | 10/06/2017 |
| K193188 | Medimaging Integrated Solution Inc. (MiiS) | MiiS Horus Eye Anterior Camera | 01/14/2020 |
| K133132 | NIDEK CO., LTD. | OPTICAL BIOMETER AL-SCAN | 06/11/2014 |
| K163564 | NIDEK CO., LTD. | SLIT LAMP SL-2000 | 05/19/2017 |
| K012416 | NIDEK TECHNOLOGIES SRL | CONFOSCAN 2 CONFOCAL MICROSCOPE | 10/26/2001 |
| K962522 | PACIFIC OPHTHALMIC SUPPLY | MODEL SL-YZ5E | 07/25/1996 |
| K063750 | REICHERT INC. | XCEL 255 SLIT LAMP | 12/20/2006 |
| K061330 | REICHERT, INC. | PSL PORTABLE SLIT LAMP | 05/25/2006 |
| K141954 | REICHERT, INC. | XCEL 455 SLIT LAMP | 10/15/2014 |
| K110129 | RIGHTMEDICAL PRODUCTS, LLC | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION | 08/30/2011 |
| K060869 | RIGHTMEDICAL PRODUCTS, LLC | RS-1000 ZOOM SLITLAMP WITH OPTION | 05/11/2006 |
| K100439 | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. | MEDIWORKS SLIT LAMP | 07/16/2010 |
| K152429 | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. | Slit Lamp Microscope | 05/11/2016 |
| K153545 | SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. | Portable Slit Lamp | 06/22/2016 |
| K131711 | SUZHOU 66 VISION TECH CO., LTD. | YZ3 PORTABLE SLIT LAMP | 05/09/2014 |
| K033190 | SUZHOU 66 VISION-TECH CO., LTD | VISION-TECH YZ SLIT LAMP, MODEL 66 | 12/04/2003 |
| K162778 | SUZHOU KANGJIE MEDICAL INC | Portable Slit Lamp Microscope | 07/21/2017 |
| K063352 | TAKAGI SEIKO CO., LTD. | ELLEX SLIT LAMP, MODEL 30XL | 03/13/2007 |
| K152535 | TAKAGI SEIKO CO., LTD. | Z5 Slit lamp microscope, Z2 Slit lamp microscope | 05/26/2016 |
| K162636 | TAKAGI SEIKO CO.LTD. | Marco Ultra M3, Marco Ultra M4 | 04/14/2017 |
| K971953 | TOMEY CORPORATION USA | CONFOSCAN | 08/14/1997 |
| K133667 | TOPCON CORP. | SLIT LAMP SL-D701 | 08/26/2014 |
| K161972 | TOPCON CORPORATION | Slit Lamp SL-D301 | 12/09/2016 |
| K110489 | TOPCON MEDICAL SYSTEMS, INC. | SLIT LAMP SL-2G | 05/23/2011 |
| K063416 | U.S. OPHTHALMIC LLC | LUXVISION SLIT LAMP | 12/07/2006 |
| K080776 | USOPHTHALMIC, LLC | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 | 09/09/2008 |
| K093021 | USOPTHALMIC, LLC | ATLANTIS SLIT LAMP | 01/28/2010 |
| K160327 | VISIA IMAGING S.R.L | ALADDIN HW3.0 | 10/05/2016 |
| K131567 | VISIA imaging S.r.l. | ALADDIN | 06/05/2014 |
| K043503 | VISX, INCORPORATED | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 | 04/05/2005 |
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