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Amo Manufacturing USA, LLC

75 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System (P930016/S067)Amo Manufacturing USA, LLC2024-08-09
STAR S4 IR Excimer Laser (P930016/S065)Amo Manufacturing USA, LLC2024-07-01
iDesign Refractive Studio (P930016/S066)Amo Manufacturing USA, LLC2024-03-22
iDesign Refractive Studio (iDesign/G301) (P930016/S064)Amo Manufacturing USA, LLC2024-03-21
iDesign Refractive Studio (P930016/S063)Amo Manufacturing USA, LLC2023-10-16
iDesign Advanced WaveScan Studio, STAR Excimer Laser System (P930016/S062)Amo Manufacturing USA, LLC2021-02-26
iDESIGN Refractive Studio (P930016/S061)Amo Manufacturing USA, LLC2020-02-14
iDESIGN Refractive Studio (P930016/S060)Amo Manufacturing USA, LLC2020-01-28
STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio (P930016/S057)Amo Manufacturing USA, LLC2019-09-09
iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems (P930016/S059)Amo Manufacturing USA, LLC2019-05-28
iDESIGN Refractive Studio (P930016/S058)Amo Manufacturing USA, LLC2019-05-03
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P990010/S008)Amo Manufacturing USA, LLC2019-04-12
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P910062/S008)Amo Manufacturing USA, LLC2019-04-12
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P930016/S056)Amo Manufacturing USA, LLC2019-04-12
iDESIGN Refractive Studio; STAR Excimer Laser System (P930016/S055)Amo Manufacturing USA, LLC2019-01-29
iDESIGNRefractive Studio, STAR Excimer Laser System (P930016/S053)Amo Manufacturing USA, LLC2018-06-15
STAR Excimer Laser System (P930016/S054)Amo Manufacturing USA, LLC2018-02-09
Star S4 IR Excimer Laser System (P930016/S051)Amo Manufacturing USA, LLC2017-07-14
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System (P930016/S048)Amo Manufacturing USA, LLC2017-06-30
Star S4 IR Excimer Laser System (P930016/S052)Amo Manufacturing USA, LLC2017-06-23
iDesign Advanced WaveScan Studio (P930016/S050)Amo Manufacturing USA, LLC2017-04-05
STAR EXCIMER LASER SYSTEM (P930016/S049)Amo Manufacturing USA, LLC2017-01-11
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM (P930016/S045)Amo Manufacturing USA, LLC2016-11-14
STAR EXCIMER LASER SYSTEM (P930016/S047)Amo Manufacturing USA, LLC2016-02-09
STAR EXCIMER LASER SYSTEM (P930016/S046)Amo Manufacturing USA, LLC2016-01-11
STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM (P930016/S044)Amo Manufacturing USA, LLC2015-05-06
STAR EXCIMER LASER SYSTEM (P990010/S007)Amo Manufacturing USA, LLC2014-10-02
STAR EXCIMER LASER SYSTEM (P930016/S043)Amo Manufacturing USA, LLC2014-10-02
STAR EXCIMER LASER SYSTEM (P910062/S007)Amo Manufacturing USA, LLC2014-10-02
STAR, S41R EXCIMER LASER SYSTEM (P990010/S004)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P990010/S006)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P930016/S042)Amo Manufacturing USA, LLC2014-05-30
STAR S4 IM EXCIMER LASER SYSTEM (P910062/S004)Amo Manufacturing USA, LLC2014-05-30
WAVESCAN WAVEFRONT SYSTEM (P930016/S040)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P910062/S006)Amo Manufacturing USA, LLC2014-05-30
WAVESCAN WAVEFRONT SYSTEM (P930016/S038)Amo Manufacturing USA, LLC2013-06-27
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S035)Amo Manufacturing USA, LLC2012-07-17
STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM (P930016/S036)Amo Manufacturing USA, LLC2011-11-17
WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68 (P930016/S034)Amo Manufacturing USA, LLC2011-03-04
STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S032)Amo Manufacturing USA, LLC2010-03-09
VISX STAR S4 IR EXCIMER LASER SYSTEM (P930016/S031)Amo Manufacturing USA, LLC2008-12-01
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S028)Amo Manufacturing USA, LLC2008-04-09
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S029)Amo Manufacturing USA, LLC2008-04-02
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM (P930016/S030)Amo Manufacturing USA, LLC2008-01-16
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S027)Amo Manufacturing USA, LLC2007-11-09
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM (P930016/S025)Amo Manufacturing USA, LLC2007-07-11
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM (P930016/S026)Amo Manufacturing USA, LLC2006-11-03
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S024)Amo Manufacturing USA, LLC2006-05-03
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S023)Amo Manufacturing USA, LLC2005-09-28
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S021)Amo Manufacturing USA, LLC2005-08-30
STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10 (P930016/S022)Amo Manufacturing USA, LLC2005-05-02
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S020)Amo Manufacturing USA, LLC2005-03-17
STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS (P930016/S019)Amo Manufacturing USA, LLC2005-02-18
STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S017)Amo Manufacturing USA, LLC2004-12-14
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM (P930016/S018)Amo Manufacturing USA, LLC2004-06-07
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM (P930016/S016)Amo Manufacturing USA, LLC2003-05-23
VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM (P930016/S015)Amo Manufacturing USA, LLC2002-08-07
VISX STAR EXCIMER LASER SYSTEM (P930016/S014)Amo Manufacturing USA, LLC2001-11-06
VISX STAR EXCIMER LASER SYSTEM (P930016/S012)Amo Manufacturing USA, LLC2001-04-27
VISX STAR S2/S3 EXCIMER LASER SYSTEM (P930016/S013)Amo Manufacturing USA, LLC2001-03-19
VISX STAR S2 AND S3 EXCIMER LASER SYSTEM (P930016/S010)Amo Manufacturing USA, LLC2000-10-18
VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) (P930016/S011)Amo Manufacturing USA, LLC2000-04-20
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) (P910062/S001)Amo Manufacturing USA, LLC2000-04-20
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) (P990010/S001)Amo Manufacturing USA, LLC2000-04-20
VISX EXCIMER LASER SYSTEM MODEL C STAR (P990010)Amo Manufacturing USA, LLC1999-11-19
VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK) (P930016/S008)Amo Manufacturing USA, LLC1999-02-23
VISX STAR S2 EXCIMER LASER SYSTEM (P930016/S007)Amo Manufacturing USA, LLC1998-11-02
VISX STAR S2 EXCIMER LASER SYSTEM (P930016/S006)Amo Manufacturing USA, LLC1998-03-20
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S005)Amo Manufacturing USA, LLC1998-01-29
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S004)Amo Manufacturing USA, LLC1997-06-12
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S003)Amo Manufacturing USA, LLC1997-04-24
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S002)Amo Manufacturing USA, LLC1996-11-07
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016/S001)Amo Manufacturing USA, LLC1996-10-15
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016)Amo Manufacturing USA, LLC1996-03-27
VISX MODELB/MODEL C EXCIMER LASER SYSTEM (P910062)Amo Manufacturing USA, LLC1995-09-29

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