Atlas FDA

HJO

108 FDA 510(k) clearances · Product code

92 daysmedian time to decision
265 days90th percentile
108clearances measured

FDA profile

Official device name
Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 13 · 2020: 19 · 2021: 14 · 2023: 18 · 2024: 18 · 2025: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
VISUREF 600 (K253834)Carl Zeiss Vision GmbH2026-03-18
HP-OCT (HP-OCT) (K231760)Cylite Pty. , Ltd.2024-03-08
Kowa SL-19 (K222372)Kowa Company , Ltd.2022-11-21
MiiS Horus Eye Anterior Camera (K193188)Medimaging Integrated Solution, Inc (Miis)2020-01-14
Sunkingdom Slit Lamp (K182306)Chongqing Sunkingdom Medical Instrument Co., Ltd.2018-11-22
IOLMaster 700 (K173771)Carl Zeiss Meditec, AG2018-08-24
SLM-1ER, SLM-2ER, SLM-3ER (K171877)Chongqing Kanghua Ruiming S&T Co., Ltd.2017-12-21
Digital Eye Anterior Camera (K170470)Medimaging Integrated Solution, Inc (Miis)2017-10-06
Portable Slit Lamp Microscope (K162778)Suzhou Kangjie Medical, Inc.2017-07-21
SL 220 (K162684)Carl Zeiss Meditec, AG2017-05-31
SLIT LAMP SL-2000 (K163564)Nidek Co., Ltd.2017-05-19
Marco Ultra M3, Marco Ultra M4 (K162636)Takagi Seiko Co., Ltd.2017-04-14
IOLMaster 700 (K170171)Carl Zeiss Meditec, AG2017-04-06
VISULUX (K161607)Carl Zeiss Meditec, AG2017-02-23
SLIT LAMP, Model: YF-100 (K161764)Chongqing Yeasn Science-Technology Co., Ltd.2017-02-16
Slit Lamp SL-D301 (K161972)Topcon Corporation2016-12-09
ALADDIN HW3.0 (K160327)Visia Imaging S.R.L.2016-10-05
Portable Slit Lamp (K153545)Shanghai Bolan Optical-Electric Co., Ltd.2016-06-22
Z5 Slit lamp microscope, Z2 Slit lamp microscope (K152535)Takagi Seiko Co., Ltd.2016-05-26
Slit Lamp Microscope (K152429)Shanghai Mediworks Precision Instruments Co. , Ltd.2016-05-11
Keeler Slit Lamp (K151394)Keeler Limited2015-09-10
IOLMaster700 (K143275)Carl Zeiss Meditec, Inc.2015-07-10
XCEL 455 SLIT LAMP (K141954)Reichert, Inc.2014-10-15
ZEISS CATARACT SUITE MARKERLESS (K141068)Carl Zeiss Meditec, AG2014-09-09
SLIT LAMP SL-D701 (K133667)Topcon Corp.2014-08-26
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) (K140451)Keeler Limited2014-07-11
DISCOVERY SYSTEM (K133062)Innovative Visual Systems2014-06-20
OPTICAL BIOMETER AL-SCAN (K133132)Nidek Co., Ltd.2014-06-11
ALADDIN (K131567)Visia Imaging S.R.L.2014-06-05
YZ3 PORTABLE SLIT LAMP (K131711)Suzhou 66 Vision Tech Co., Ltd.2014-05-09
KOWA SL-17 (K133755)Kowa Co. , Ltd.2014-03-11
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION (K133476)Carl Zeiss Meditec, AG2014-02-12
KEELER SLIT LAMP H-SERIES (K131589)Keeler, Ltd.2013-06-27
IOLMASTER 500 (K122418)Carl Zeiss Meditec, AG2013-04-12
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION (K110129)Rightmedical Products, LLC2011-08-30
SLIT LAMP SL-2G (K110489)Topcon Medical Systems, Inc.2011-05-23
IOLMASTER 500 (K101182)Carl Zeiss Meditec, AG2010-11-03
MEDIWORKS SLIT LAMP (K100439)Shanghai Mediworks Precision Instruments Co. , Ltd.2010-07-16
SLIT LAMP BO 900, BQ 900, BP900 (K100202)Haag-Streit AG2010-03-19
PSL CLASSIC SLIT LAMP (K100500)Keeler Instruments, Inc.2010-03-09
ATLANTIS SLIT LAMP (K093021)Us Opthalmic, LLC2010-01-28
LED LAMP OR OTHER (K092883)Intravista Medical Systems, Inc.2009-12-18
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (K093639)Huvitz Co., Ltd.2009-12-03
LENSTAR, MODEL LS900 (K082891)Haag-Streit AG2009-10-20
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 (K080776)Us Ophthalmic, LLC2008-09-09
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES (K082031)Appasamy Associates2008-07-31
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) (K072861)Acheve Technology, Inc.2008-06-24
SLIT LAMP (K073190)Huvitz Co., Ltd.2008-01-11
ELLEX SLIT LAMP, MODEL 30XL (K063352)Takagi Seiko Co., Ltd.2007-03-13
XCEL 255 SLIT LAMP (K063750)Reichert, Inc.2006-12-20
KOWA SL-15 (K063640)Kowa Co. , Ltd.2006-12-18
LUXVISION SLIT LAMP (K063416)Us Ophthalmic, LLC2006-12-07
PSL PORTABLE SLIT LAMP (K061330)Reichert, Inc.2006-05-25
RS-1000 ZOOM SLITLAMP WITH OPTION (K060869)Rightmedical Products, LLC2006-05-11
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 (K043503)Visx, Incorporated2005-04-05
VISION-TECH YZ SLIT LAMP, MODEL 66 (K033190)Suzhou 66 Vision-Tech Co., Ltd.2003-12-04
DOCUMENTING LASER SLIT LAMP, DP 2010 (K012873)Bausch & Lomb, Inc.2001-11-19
CONFOSCAN 2 CONFOCAL MICROSCOPE (K012416)Nidek Technologies Srl2001-10-26
IOLMASTER (K993357)Carl Zeiss, Inc.2000-03-20
SL990, SL980, SL950 (K992836)Cso1999-11-09
BC 900 SLIT LAMP (K982057)Haag-Streit AG1998-08-14
KEELER TEARSCOPE-PLUS (K973064)Keeler Instruments, Inc.1998-04-07
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 (K974467)Aesculap-Meditec North America1998-02-19
CONFOSCAN (K971953)Tomey Corporation USA1997-08-14
CONFOCAL MICROSCOPE (K970414)Con-S , Ltd.1997-07-15
RODENSTOCK SLITLAMP (MODEL 5000 & 4000) (K962532)Expertech Assoc., Inc.1996-07-25
MODEL SL-YZ5E (K962522)Pacific Ophthalmic Supply1996-07-25
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B (K954782)Kowa Optimed, Inc.1995-11-24
BOBES SLIT LAMP (K945445)Bobes S.A.1995-10-17
904 SLIT LAMP (K953965)Clement Clarke, Inc.1995-09-27
SLIT LAMP AIA 11 (K953030)Naveen Intl., Inc.1995-07-12
NEITZ SLIT LAMP SL-H2 (K951341)Neitz Instruments Company, Ltd.1995-06-15
OTI MODEL 78-60 (K951184)Oti Medical, LLC1995-05-12
NEITZ SLIT LAMP SL-H1 (K951340)Neitz Instruments Company, Ltd.1995-04-10
XCEL SLIT LAMP (K951054)Leica, Inc.1995-03-22
TOMEY EM-1000 SPECULAR MICROSCOPE (K944910)Tomey Corporation USA1994-11-22
SLIT LAMP, H-201 (K936209)Canon USA, Inc.1994-04-01
TALIA LASER SLIT (K930518)Talia Technology , Ltd.1994-01-25
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR (K925641)Carl Zeiss, Inc.1993-09-09
MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS (K930438)Marco Ophthalmic, Inc.1993-08-09
BURTON SLIT LAMP - MODEL 850 (K924783)R.H. Burton Co.1993-04-14
BURTON HAND HELD SLIT LAMP - MODEL SL750 (K924770)R.H. Burton Co.1993-01-27
BURTON SLIT LAMP - MODEL 2000 (K924782)R.H. Burton Co.1993-01-27
BURTON SLIT LAMP (K924787)R.H. Burton Co.1993-01-27
OPACITRAC (K915356)Oculon Corp.1992-02-21
LASER FLARE METER (K913852)Kowa Optimed, Inc.1992-02-07
TANDEM SCANNING MICROSCOPE (K912514)Tandem Scanning Corp.1991-12-16
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE (K910980)Site Microsurgical Systems, Inc.1991-05-22
WOODLYN SLIT LAMP MODEL HR-1 (K900476)Woodlyn, Inc.1990-02-21
WOODLYN CLASSIC SLIT LAMP MODEL SMM (K900477)Woodlyn, Inc.1990-02-21
LASER FLARE CELL METER FC-1000 (K880920)Kowa Optimed, Inc.1988-09-27
ZEISS 40 SL/P PHOTO SLIT LAMP (K874160)Carl Zeiss, Inc.1988-01-27
OCS 100 (OCULAR COMPARATOR SYSTEM) (K874220)Ocular Instruments, Inc.1987-12-23
MLC ENDOTHELIAL CELL COUNTER (K863970)Mlc Technologies1986-12-29
OPM SLIT LAMP MODEL P-1 & MODEL P-3 (K863048)Optek Medico Co., Ltd.1986-09-03
CORNEAL MODELING SYSTEM (K862379)Computed Anatomy, Inc.1986-08-25
BAUSCH & LOMB PSL-3000 SLIT LAMP (K862520)Bausch & Lomb, Inc.1986-07-11
BAUSCH & LOMB CSL-1000 SLIT LAMP (K862515)Bausch & Lomb, Inc.1986-07-11
BAUSCH & LOMB OSL-2000 SLIT LAMP (K862516)Bausch & Lomb, Inc.1986-07-11
OPM SLIT LAMP MODEL P-1 (K861854)Optek Medico Co., Ltd.1986-07-11
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