FDA Product Code
FDA Product Code HJO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1850
510(k) Clearances — 109 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | 2026-09-18 | Traditional | PDF ↗ |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 | Traditional | PDF ↗ |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | 2024-03-08 | Traditional | PDF ↗ |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 | Traditional | PDF ↗ |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 | Traditional | PDF ↗ |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018-08-24 | Traditional | PDF ↗ |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 | Traditional | PDF ↗ |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 | Traditional | PDF ↗ |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | 2017-07-21 | Traditional | PDF ↗ |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017-05-31 | Traditional | PDF ↗ |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | 2017-05-19 | Traditional | PDF ↗ |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017-04-14 | Traditional | PDF ↗ |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017-04-06 | Traditional | PDF ↗ |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | 2017-02-23 | Traditional | PDF ↗ |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 | Traditional | PDF ↗ |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016-12-09 | Traditional | PDF ↗ |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | 2016-10-05 | Traditional | PDF ↗ |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | 2016-06-22 | Traditional | PDF ↗ |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016-05-26 | Traditional | PDF ↗ |
| K152429 | Slit Lamp Microscope | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-05-11 | Traditional | PDF ↗ |
| K151394 | Keeler Slit Lamp | Keeler Limited | 2015-09-10 | Traditional | PDF ↗ |
| K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015-07-10 | Traditional | PDF ↗ |
| K141954 | XCEL 455 SLIT LAMP | Reichert, Inc. | 2014-10-15 | Special | PDF ↗ |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | Carl Zeiss Meditec, AG | 2014-09-09 | Traditional | PDF ↗ |
| K133667 | SLIT LAMP SL-D701 | Topcon Corp. | 2014-08-26 | Traditional | PDF ↗ |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | Keeler Limited | 2014-07-11 | Traditional | PDF ↗ |
| K133062 | DISCOVERY SYSTEM | Innovative Visual Systems | 2014-06-20 | Traditional | PDF ↗ |
| K133132 | OPTICAL BIOMETER AL-SCAN | Nidek Co., Ltd. | 2014-06-11 | Traditional | PDF ↗ |
| K131567 | ALADDIN | Visia Imaging S.R.L. | 2014-06-05 | Traditional | PDF ↗ |
| K131711 | YZ3 PORTABLE SLIT LAMP | Suzhou 66 Vision Tech Co., Ltd. | 2014-05-09 | Traditional | PDF ↗ |
| K133755 | KOWA SL-17 | Kowa Co. , Ltd. | 2014-03-11 | Traditional | PDF ↗ |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | Carl Zeiss Meditec, AG | 2014-02-12 | Traditional | PDF ↗ |
| K131589 | KEELER SLIT LAMP H-SERIES | Keeler, Ltd. | 2013-06-27 | Abbreviated | PDF ↗ |
| K122418 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2013-04-12 | Traditional | PDF ↗ |
| K110129 | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION | Rightmedical Products, LLC | 2011-08-30 | Traditional | PDF ↗ |
| K110489 | SLIT LAMP SL-2G | Topcon Medical Systems, Inc. | 2011-05-23 | Traditional | PDF ↗ |
| K101182 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2010-11-03 | Traditional | PDF ↗ |
| K100439 | MEDIWORKS SLIT LAMP | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2010-07-16 | Traditional | PDF ↗ |
| K100202 | SLIT LAMP BO 900, BQ 900, BP900 | Haag-Streit AG | 2010-03-19 | Traditional | PDF ↗ |
| K100500 | PSL CLASSIC SLIT LAMP | Keeler Instruments, Inc. | 2010-03-09 | Traditional | PDF ↗ |
| K093021 | ATLANTIS SLIT LAMP | Us Opthalmic, LLC | 2010-01-28 | Traditional | PDF ↗ |
| K092883 | LED LAMP OR OTHER | Intravista Medical Systems, Inc. | 2009-12-18 | Traditional | PDF ↗ |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | Huvitz Co., Ltd. | 2009-12-03 | Traditional | PDF ↗ |
| K082891 | LENSTAR, MODEL LS900 | Haag-Streit AG | 2009-10-20 | Traditional | PDF ↗ |
| K080776 | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 | Us Ophthalmic, LLC | 2008-09-09 | Traditional | PDF ↗ |
| K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | Appasamy Associates | 2008-07-31 | Traditional | PDF ↗ |
| K072861 | CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) | Acheve Technology, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K073190 | SLIT LAMP | Huvitz Co., Ltd. | 2008-01-11 | Traditional | PDF ↗ |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Takagi Seiko Co., Ltd. | 2007-03-13 | Traditional | PDF ↗ |
| K063750 | XCEL 255 SLIT LAMP | Reichert, Inc. | 2006-12-20 | Traditional | PDF ↗ |
| K063640 | KOWA SL-15 | Kowa Co. , Ltd. | 2006-12-18 | Special | PDF ↗ |
| K063416 | LUXVISION SLIT LAMP | Us Ophthalmic, LLC | 2006-12-07 | Traditional | PDF ↗ |
| K061330 | PSL PORTABLE SLIT LAMP | Reichert, Inc. | 2006-05-25 | Abbreviated | PDF ↗ |
| K060869 | RS-1000 ZOOM SLITLAMP WITH OPTION | Rightmedical Products, LLC | 2006-05-11 | Traditional | PDF ↗ |
| K043503 | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 | Visx, Incorporated | 2005-04-05 | Traditional | PDF ↗ |
| K033190 | VISION-TECH YZ SLIT LAMP, MODEL 66 | Suzhou 66 Vision-Tech Co., Ltd. | 2003-12-04 | Traditional | PDF ↗ |
| K012873 | DOCUMENTING LASER SLIT LAMP, DP 2010 | Bausch & Lomb, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K012416 | CONFOSCAN 2 CONFOCAL MICROSCOPE | Nidek Technologies Srl | 2001-10-26 | Traditional | PDF ↗ |
| K993357 | IOLMASTER | Carl Zeiss, Inc. | 2000-03-20 | Traditional | PDF ↗ |
| K992836 | SL990, SL980, SL950 | Cso | 1999-11-09 | Traditional | PDF ↗ |
| K982057 | BC 900 SLIT LAMP | Haag-Streit AG | 1998-08-14 | Traditional | PDF ↗ |
| K973064 | KEELER TEARSCOPE-PLUS | Keeler Instruments, Inc. | 1998-04-07 | Traditional | PDF ↗ |
| K974467 | AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 | Aesculap-Meditec North America | 1998-02-19 | Traditional | PDF ↗ |
| K971953 | CONFOSCAN | Tomey Corporation USA | 1997-08-14 | Traditional | PDF ↗ |
| K970414 | CONFOCAL MICROSCOPE | Con-S , Ltd. | 1997-07-15 | Traditional | PDF ↗ |
| K962532 | RODENSTOCK SLITLAMP (MODEL 5000 & 4000) | Expertech Assoc., Inc. | 1996-07-25 | Traditional | PDF ↗ |
| K962522 | MODEL SL-YZ5E | Pacific Ophthalmic Supply | 1996-07-25 | Traditional | PDF ↗ |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | Kowa Optimed, Inc. | 1995-11-24 | Traditional | PDF ↗ |
| K945445 | BOBES SLIT LAMP | Bobes S.A. | 1995-10-17 | Traditional | PDF ↗ |
| K953965 | 904 SLIT LAMP | Clement Clarke, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953030 | SLIT LAMP AIA 11 | Naveen Intl., Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K951341 | NEITZ SLIT LAMP SL-H2 | Neitz Instruments Company, Ltd. | 1995-06-15 | Traditional | PDF ↗ |
| K951184 | OTI MODEL 78-60 | Oti Medical, LLC | 1995-05-12 | Traditional | PDF ↗ |
| K951340 | NEITZ SLIT LAMP SL-H1 | Neitz Instruments Company, Ltd. | 1995-04-10 | Traditional | PDF ↗ |
| K951054 | XCEL SLIT LAMP | Leica, Inc. | 1995-03-22 | Traditional | PDF ↗ |
| K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE | Tomey Corporation USA | 1994-11-22 | Traditional | PDF ↗ |
| K936209 | SLIT LAMP, H-201 | Canon USA, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K930518 | TALIA LASER SLIT | Talia Technology , Ltd. | 1994-01-25 | Traditional | PDF ↗ |
| K925641 | ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR | Carl Zeiss, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | Marco Ophthalmic, Inc. | 1993-08-09 | Traditional | PDF ↗ |
| K924783 | BURTON SLIT LAMP - MODEL 850 | R.H. Burton Co. | 1993-04-14 | Traditional | PDF ↗ |
| K924770 | BURTON HAND HELD SLIT LAMP - MODEL SL750 | R.H. Burton Co. | 1993-01-27 | Traditional | PDF ↗ |
| K924782 | BURTON SLIT LAMP - MODEL 2000 | R.H. Burton Co. | 1993-01-27 | Traditional | PDF ↗ |
| K924787 | BURTON SLIT LAMP | R.H. Burton Co. | 1993-01-27 | Traditional | PDF ↗ |
| K915356 | OPACITRAC | Oculon Corp. | 1992-02-21 | Traditional | PDF ↗ |
| K913852 | LASER FLARE METER | Kowa Optimed, Inc. | 1992-02-07 | Traditional | PDF ↗ |
| K912514 | TANDEM SCANNING MICROSCOPE | Tandem Scanning Corp. | 1991-12-16 | Traditional | PDF ↗ |
| K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE | Site Microsurgical Systems, Inc. | 1991-05-22 | Traditional | PDF ↗ |
| K900477 | WOODLYN CLASSIC SLIT LAMP MODEL SMM | Woodlyn, Inc. | 1990-02-21 | Traditional | PDF ↗ |
| K900476 | WOODLYN SLIT LAMP MODEL HR-1 | Woodlyn, Inc. | 1990-02-21 | Traditional | PDF ↗ |
| K880920 | LASER FLARE CELL METER FC-1000 | Kowa Optimed, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K874160 | ZEISS 40 SL/P PHOTO SLIT LAMP | Carl Zeiss, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K874220 | OCS 100 (OCULAR COMPARATOR SYSTEM) | Ocular Instruments, Inc. | 1987-12-23 | Traditional | PDF ↗ |
| K863970 | MLC ENDOTHELIAL CELL COUNTER | Mlc Technologies | 1986-12-29 | Traditional | PDF ↗ |
| K863048 | OPM SLIT LAMP MODEL P-1 & MODEL P-3 | Optek Medico Co., Ltd. | 1986-09-03 | Traditional | PDF ↗ |
| K862379 | CORNEAL MODELING SYSTEM | Computed Anatomy, Inc. | 1986-08-25 | Traditional | PDF ↗ |
| K862520 | BAUSCH & LOMB PSL-3000 SLIT LAMP | Bausch & Lomb, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K862515 | BAUSCH & LOMB CSL-1000 SLIT LAMP | Bausch & Lomb, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K862516 | BAUSCH & LOMB OSL-2000 SLIT LAMP | Bausch & Lomb, Inc. | 1986-07-11 | Traditional | PDF ↗ |
Product code HJO · Class II · Ophthalmic. Data: openFDA.