Panels › Ophthalmic › Product code HJO · Class 2
Biomicroscope, Slit-Lamp, Ac-Powered
Regulation 886.1850
2510(k)s in 12 months (109 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in HJO
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 9 | 6 |
| Bausch & Lomb, Inc. | 4 | 0 |
| Carl Zeiss, Inc. | 4 | 0 |
| Haag-Streit AG | 3 | 1 |
| R.H. Burton Co. | 4 | 0 |
| Keeler Limited | 3 | 0 |
| Kowa Co. , Ltd. | 3 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Nidek Co., Ltd. | 2 | 1 |
| Reichert, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K262637 | SLIT LAMP SL-D4 (Type: LED) Topcon Corporation, JP | HJO |
| Mar 18, 2026 | K253834 | VISUREF 600 Carl Zeiss Vision GmbH, DE | HJO |
| Mar 8, 2024 | K231760 | HP-OCT (HP-OCT) Cylite Pty. , Ltd., AU | HJO |
| Nov 21, 2022 | K222372 | Kowa SL-19 Kowa Company , Ltd., JP | HJO |
| Jan 14, 2020 | K193188 | MiiS Horus Eye Anterior Camera Medimaging Integrated Solution, Inc (Miis), CN | HJO |
| Nov 22, 2018 | K182306 | Sunkingdom Slit Lamp Chongqing Sunkingdom Medical Instrument Co., Ltd., CN | HJO |
| Aug 24, 2018 | K173771 | IOLMaster 700 Carl Zeiss Meditec, AG, DE | HJO |
| Dec 21, 2017 | K171877 | SLM-1ER, SLM-2ER, SLM-3ER Chongqing Kanghua Ruiming S&T Co., Ltd., CN | HJO |
| Oct 6, 2017 | K170470 | Digital Eye Anterior Camera Medimaging Integrated Solution, Inc (Miis), TW | HJO |
| Jul 21, 2017 | K162778 | Portable Slit Lamp Microscope Suzhou Kangjie Medical, Inc., CN | HJO |
| May 31, 2017 | K162684 | SL 220 Carl Zeiss Meditec, AG, DE | HJO |
| May 19, 2017 | K163564 | SLIT LAMP SL-2000 Nidek Co., Ltd., JP | HJO |
| Apr 14, 2017 | K162636 | Marco Ultra M3, Marco Ultra M4 Takagi Seiko Co., Ltd., JP | HJO |
| Apr 6, 2017 | K170171 | IOLMaster 700 Carl Zeiss Meditec, AG, DE | HJO |
| Feb 23, 2017 | K161607 | VISULUX Carl Zeiss Meditec, AG, DE | HJO |
| Feb 16, 2017 | K161764 | SLIT LAMP, Model: YF-100 Chongqing Yeasn Science-Technology Co., Ltd., CN | HJO |
| Dec 9, 2016 | K161972 | Slit Lamp SL-D301 Topcon Corporation, JP | HJO |
| Oct 5, 2016 | K160327 | ALADDIN HW3.0 Visia Imaging S.R.L., IT | HJO |
| Jun 22, 2016 | K153545 | Portable Slit Lamp Shanghai Bolan Optical-Electric Co., Ltd., CN | HJO |
| May 26, 2016 | K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope Takagi Seiko Co., Ltd., JP | HJO |
| May 11, 2016 | K152429 | Slit Lamp Microscope Shanghai Mediworks Precision Instruments Co. , Ltd., CN | HJO |
| Sep 10, 2015 | K151394 | Keeler Slit Lamp Keeler Limited, GB | HJO |
| Jul 10, 2015 | K143275 | IOLMaster700 Carl Zeiss Meditec, Inc. | HJO |
| Oct 15, 2014 | K141954 | XCEL 455 SLIT LAMP Reichert, Inc. | HJO |
| Sep 9, 2014 | K141068 | ZEISS CATARACT SUITE MARKERLESS Carl Zeiss Meditec, AG | HJO |
| Aug 26, 2014 | K133667 | SLIT LAMP SL-D701 Topcon Corp. | HJO |
| Jul 11, 2014 | K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) Keeler Limited | HJO |
| Jun 20, 2014 | K133062 | DISCOVERY SYSTEM Innovative Visual Systems | HJO |
| Jun 11, 2014 | K133132 | OPTICAL BIOMETER AL-SCAN Nidek Co., Ltd. | HJO |
| Jun 5, 2014 | K131567 | ALADDIN Visia Imaging S.R.L. | HJO |
| May 9, 2014 | K131711 | YZ3 PORTABLE SLIT LAMP Suzhou 66 Vision Tech Co., Ltd., CN | HJO |
| Mar 11, 2014 | K133755 | KOWA SL-17 Kowa Co. , Ltd., JP | HJO |
| Feb 12, 2014 | K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION Carl Zeiss Meditec, AG | HJO |
| Jun 27, 2013 | K131589 | KEELER SLIT LAMP H-SERIES Keeler, Ltd., GB | HJO |
| Apr 12, 2013 | K122418 | IOLMASTER 500 Carl Zeiss Meditec, AG | HJO |
| Aug 30, 2011 | K110129 | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION Rightmedical Products, LLC, CA | HJO |
| May 23, 2011 | K110489 | SLIT LAMP SL-2G Topcon Medical Systems, Inc. | HJO |
| Nov 3, 2010 | K101182 | IOLMASTER 500 Carl Zeiss Meditec, AG | HJO |
| Jul 16, 2010 | K100439 | MEDIWORKS SLIT LAMP Shanghai Mediworks Precision Instruments Co. , Ltd. | HJO |
| Mar 19, 2010 | K100202 | SLIT LAMP BO 900, BQ 900, BP900 Haag-Streit AG, CH | HJO |
| Mar 9, 2010 | K100500 | PSL CLASSIC SLIT LAMP Keeler Instruments, Inc. | HJO |
| Jan 28, 2010 | K093021 | ATLANTIS SLIT LAMP Us Opthalmic, LLC | HJO |
| Dec 18, 2009 | K092883 | LED LAMP OR OTHER Intravista Medical Systems, Inc. | HJO |
| Dec 3, 2009 | K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 Huvitz Co., Ltd. | HJO |
| Oct 20, 2009 | K082891 | LENSTAR, MODEL LS900 Haag-Streit AG | HJO |
| Sep 9, 2008 | K080776 | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 Us Ophthalmic, LLC | HJO |
| Jul 31, 2008 | K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES Appasamy Associates, IN | HJO |
| Jun 24, 2008 | K072861 | CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) Acheve Technology, Inc. | HJO |
| Jan 11, 2008 | K073190 | SLIT LAMP Huvitz Co., Ltd. | HJO |
| Mar 13, 2007 | K063352 | ELLEX SLIT LAMP, MODEL 30XL Takagi Seiko Co., Ltd., AU | HJO |
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