Atlas FDA

HNO

83 FDA 510(k) clearances · Product code

90 daysmedian time to decision
235 days90th percentile
83clearances measured

FDA profile

Official device name
Keratome, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 1,397 · 2017: 2,112 · 2018: 2,265 · 2019: 816 · 2020: 405 · 2021: 72
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
VisuMax Femtosecond Laser (K173371)Carl Zeiss Meditec, Inc.2018-04-13
EPI K Console (K172994)Moria SA2017-10-26
EPIVISION SL SYSTEM (K072102)Gebauer Medizintechnik GmbH2009-01-16
CARRIAZO-PENDULAR MICROKERATOME (K082043)Schwind Eye-Tech-Solutions GmbH & Co. KG2008-08-01
ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465)Bausch & Lomb, Inc.2006-09-06
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891)Hawken Industries2006-03-23
NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486)Norwood Abbey , Ltd.2005-07-06
EPI-K (K043183)Moria SA2005-03-25
AMADEUS II EPIKERATOME (K043150)Sis Ltd., Surgical Instrument Systems2005-01-31
MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083)Biovision AG2004-11-16
CENTURION SES EPIKERATOME (K042810)Norwood Abbey , Ltd.2004-10-28
MB 105 MILLENNIUM BLADES (K041110)Millennium Biomedical, Inc.2004-10-13
EPITOME SYSTEM (K041206)Gebauer Medizintechnik GmbH2004-09-15
CARRIAZO PENDULAR (K032910)Schwind Eye-Tech-Solutions GmbH & Co. KG2004-08-30
M3 MICROKERATOME (K032836)Moria SA2004-06-18
M2 COMPATIBLE MICROKERATOME BLADE (K033457)Micro Specialties, Inc.2004-05-25
PRIZM KERATOME BLADE, MODEL MK8512M2 (K033236)Surgin Surgical Instrumentation, Inc.2004-03-26
ZYOPTIX XP MICROKERATOME (K040204)Bausch & Lomb, Inc.2004-03-22
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (K033182)Surgin Surgical Instrumentation, Inc.2004-01-30
MED-LOGICS, MODEL ML7090 (K033293)Med-Logics, Inc.2004-01-13
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME (K032978)Ciba Vision Corporation2003-10-20
DISPOSABLE N-PE MICKROKERATOME BLADES (K032297)Oasis Medical, Inc.2003-08-26
CENTURION SES EPIKERATOME (K031735)Ciba Vision Corporation2003-08-21
DISPOSABLE M2-PE MICROKERATOME BLADES (K030401)Oasis Medical, Inc.2003-06-19
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK (K030891)Surgistar, Inc.2003-06-17
KERATOME BLADE 200200 & 600600 (K020482)Micro Specialties, Inc.2002-12-16
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (K022982)Med-Logics, Inc.2002-11-15
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (K022716)Med-Logics, Inc.2002-10-11
DISPOSABLE N-PE MICROKERATOME BLADES (K022205)Oasis Medical, Inc.2002-10-03
HANSATOME EXCELLUS MICROKERATOME (K021640)Bausch & Lomb, Inc.2002-06-19
BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (K020079)Blade Works, Inc.2002-04-19
VISTITOME 20-10 MICROKERATOME (K014000)Biovision AG2002-03-11
MB 103 MILLENNIUM BLADES (K011833)Millennium Biomedical, Inc.2002-02-15
MB 102 MILLENNIUM BLADES (K020122)Millennium Biomedical, Inc.2002-02-15
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI (K013337)Surgin, Inc.2001-12-13
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB (K011195)Surgin Surgical Instrumentation, Inc.2001-11-06
ML BLADE, MODEL ML7030 (K010872)Med-Logics, Inc.2001-06-22
HANSATOME MICROKERATOME (K010260)Bausch & Lomb, Inc.2001-04-27
DISPOSABLE CB-PE MICROKERATOME BLADES (K003820)Oasis Medical, Inc.2001-03-08
MEDLOGICS ML 4000, MODEL 4000 (K002515)Med-Logics, Inc.2001-02-22
MILLENNIUM BLADES, MODEL MB101 (K003143)Millennium Biomedical, Inc.2000-12-11
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES (K002849)Surgical Specialties Corp2000-10-18
DISPOSABLE H-PE MICROKERATOME BLADES (K001464)Oasis2000-10-02
DISPOSABLE MICROKERATOME BLADES-PE (K001176)Oasis Medical, Inc.2000-09-21
REFRACTIVE SURGERY BLADES (K001806)Millennium Biomedical, Inc.2000-09-12
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144)Lasersight Technologies, Inc.2000-05-05
BLADEWORKS MICROKERATOME BLADE (K993225)Blade Works, Inc.2000-03-20
MSP M/K BLADE (K993122)Medical Sterile Products, Inc.2000-03-16
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (K994015)Surgin Surgical Instrumentation, Inc.2000-03-15
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) (K993190)Surgical Instrument Systems (Sis), Ltd.2000-02-10
ULTRASHAPER KERATOME (K990227)Lasersight Technologies, Inc.2000-01-31
RICROKERATOME BLADE (K992978)Surgistar, Inc.1999-11-16
MICROKERATOME, MODEL MK-2000 (K990900)Nidek, Inc.1999-09-24
KERAVISION VACUUM RING SYSTEM (K984540)Keravision, Inc.1999-04-28
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) (K981554)Micra Instruments , Ltd.1998-12-22
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME (K980675)Summit Technology, Inc.1998-12-22
BARRON MICROKERATOME SYSTEM, MODEL B2000 (K983317)Barron Precision Instruments, LLC1998-12-02
ONE UP DISPOSABLE KERATOME HEAD (K981742)Moria, Inc.1998-08-25
FLAPMAKER DISPOSABLE MICROKERATOME (K981155)Hawken Industries1998-08-14
ML MICROKERATOME (K981071)Med-Logics, Inc.1998-07-23
SCMD-1000 (K980985)Howard Instruments, Inc.1998-05-01
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) (K980510)Micro Specialties, Inc.1998-05-01
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 (K980508)Micro Specialties, Inc.1998-05-01
MICROKERATOME OR THE MATE (K974598)Howard Instruments, Inc.1998-04-22
PLANCON MICROLAMELLAR KERATOME EVOLUTION (K980924)Plancon Instruments1998-04-15
AUTOMATED DISPOSABLE KERATOME (ADK) (K974004)Lasersight Technologies, Inc.1998-01-08
HANSATOME MICROKERATOME (K972808)Chiron Vision Corp.1997-10-24
CBALK-1000 BLADE (K972727)Howard Instruments, Inc.1997-10-10
INNOVATOME MICROKERATOME (K973294)Innovative Optics, Inc.1997-10-03
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) (K970377)Plancon Instruments1997-03-31
ML MICROKERATOME BLADE (K962661)Med-Logics, Inc.1996-12-09
PLANCON MIRCOLAMELLAR KERATOME (K960395)Plancon Instruments1996-04-26
BARRAQUER-KRUMEICH REFRACTIVE SET (K954058)Eyetech M.V.A.1995-11-06
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT (K941550)Chiron Vision Corp.1994-11-22
SCMD KERATOME (K935342)S.C.M.D. Keratomes of Arizona1994-04-01
AUTOMATIC CORNEAL SHAPER (K913697)Hansa Research & Development, Inc.1991-11-05
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY (K911062)Storz Instrument Co.1991-05-22
STORZ DRAEGER ROTOR KERATOME (K904845)Storz Instrument Co.1991-01-22
KERATOME (K903912)Micro Precision Instrument Co.1990-10-17
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE (K870807)Allergan, Inc.1987-05-29
BKS-42 DISPOSABLE VACUUM TUBING PACK (K864065)Allergan, Inc.1986-12-15
BARRAQUER-KRUMEICH REFRACTIVE SET (K860001)American Medical Optics1986-02-04
ELECTRO-KERATOTOME, LINE-OPERATED (K760726)Storz Instrument Co.1976-10-05

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Every clearance here is in the API, with alerts when new ones post.