Amo Manufacturing Usa L L C

FDA Filings

This page includes the latest FDA filings for Amo Manufacturing Usa L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006695864
FEI Number3006695864
NameAMO Manufacturing USA, LLC
Owner & OperatorJohnson & Johnson Surgical Vision, Inc.
Contact Address1700 E St Andrew Place
Santa Ana CA 92705 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address510 Cottonwood Drive
Milpitas, CA 95035 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
AMO Manufacturing USA, LLC
CATALYS Precision Laser System2021-04-07
AMO Manufacturing USA, LLC
iDesign Advanced WaveScan Studio, STAR Excimer Laser System2021-02-26
AMO Manufacturing USA, LLC
iDESIGN Refractive Studio2020-02-14
AMO Manufacturing USA, LLC
iDESIGN Refractive Studio2020-01-28
AMO Manufacturing USA, LLC
iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems2019-05-28
AMO Manufacturing USA, LLC
iDESIGN Refractive Studio2019-05-03
AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System2019-04-12
AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System2019-04-12
AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System2019-04-12
AMO Manufacturing USA, LLC
iDESIGN Refractive Studio; STAR Excimer Laser System2019-01-29
AMO Manufacturing USA, LLC
Catalys Precision Laser System2018-11-09
AMO Manufacturing USA, LLC
iDESIGNRefractive Studio, STAR Excimer Laser System2018-06-15
AMO Manufacturing USA, LLC
STAR Excimer Laser System2018-02-09
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Catalys Precision Laser System2017-09-15
AMO Manufacturing USA, LLC
Catalys Precision Laser System2017-08-25
AMO Manufacturing USA, LLC
Star S4 IR Excimer Laser System2017-07-14
AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System2017-06-30
AMO Manufacturing USA, LLC
Star S4 IR Excimer Laser System2017-06-23
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Catalys Precision Laser System2017-06-15
AMO Manufacturing USA, LLC
iDesign Advanced WaveScan Studio2017-04-05
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2017-01-11
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Excimer laser system2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Ophthalmic femtosecond laser2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Unit, phacofragmentation2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Ophthalmic femtosecond laser2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Unit, phacofragmentation2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Ophthalmic femtosecond laser2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Ophthalmic femtosecond laser2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Unit, phacofragmentation2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Unit, phacofragmentation2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Powered laser surgical instrument2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Keratome, ac-powered2016-12-22
AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]
Unit, phacofragmentation2016-12-22
AMO Manufacturing USA, LLC
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM2016-11-14
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2016-02-09
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2016-01-11
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM2015-05-06
AMO MANUFACTURING USA, LLC
IFS ADVANCED FEMTOSECOND LASER SYSTEM2015-01-06
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2014-10-02
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2014-10-02
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM2014-10-02
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO2014-05-30
AMO Manufacturing USA, LLC
STAR, S41R EXCIMER LASER SYSTEM2014-05-30
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO2014-05-30
AMO Manufacturing USA, LLC
WAVESCAN WAVEFRONT SYSTEM2014-05-30
AMO Manufacturing USA, LLC
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO2014-05-30
AMO Manufacturing USA, LLC
STAR S4 IM EXCIMER LASER SYSTEM2014-05-30
AMO Manufacturing USA, LLC
WAVESCAN WAVEFRONT SYSTEM2013-06-27
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)2012-07-17
AMO Manufacturing USA, LLC
STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM2011-11-17
AMO Manufacturing USA, LLC
WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.682011-03-04
AMO Manufacturing USA, LLC
STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)2010-03-09
AMO Manufacturing USA, LLC
VISX STAR S4 IR EXCIMER LASER SYSTEM2008-12-01
AMO Manufacturing USA, LLC
STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM2008-04-09
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM2008-01-16
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)2007-11-09
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM2007-07-11
AMO Manufacturing USA, LLC
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM2006-11-03
AMO Manufacturing USA, LLC
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM2006-05-03
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM2005-09-28
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM2005-08-30
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.102005-05-02
AMO Manufacturing USA, LLC
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)2005-03-17
AMO Manufacturing USA, LLC
STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS2005-02-18
AMO Manufacturing USA, LLC
STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM2004-12-14
AMO Manufacturing USA, LLC
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM2003-05-23
AMO Manufacturing USA, LLC
VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM2002-08-07
AMO Manufacturing USA, LLC
VISX STAR EXCIMER LASER SYSTEM2001-11-06
AMO Manufacturing USA, LLC
VISX STAR EXCIMER LASER SYSTEM2001-04-27
AMO Manufacturing USA, LLC
VISX STAR S2/S3 EXCIMER LASER SYSTEM2001-03-19
AMO Manufacturing USA, LLC
VISX STAR S2 AND S3 EXCIMER LASER SYSTEM2000-10-18
AMO Manufacturing USA, LLC
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)2000-04-20
AMO Manufacturing USA, LLC
VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)2000-04-20
AMO Manufacturing USA, LLC
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)2000-04-20
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODEL C STAR1999-11-19
AMO Manufacturing USA, LLC
VISX STAR S2 EXCIMER LASER SYSTEM1998-11-02
AMO Manufacturing USA, LLC
VISX STAR S2 EXCIMER LASER SYSTEM1998-03-20
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1998-01-29
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1997-06-12
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1997-04-24
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1996-11-07
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1996-10-15
AMO Manufacturing USA, LLC
VISX EXCIMER LASER SYSTEM MODELS B AND C1996-03-27
AMO Manufacturing USA, LLC
VISX MODELB/MODEL C EXCIMER LASER SYSTEM1995-09-29

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