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 Number: 3006695864
• FEI Number: 3006695864
• Name: AMO Manufacturing USA, LLC
• Owner & Operator: Johnson & Johnson Surgical Vision, Inc.
• Contact Address: 1700 E St Andrew Place ; Santa Ana CA 92705 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 510 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	Device	Date
PMN K210701 AMO Manufacturing USA, LLC	CATALYS Precision Laser System	2021-04-07
PMA P930016S062 AMO Manufacturing USA, LLC	iDesign Advanced WaveScan Studio, STAR Excimer Laser System	2021-02-26
PMA P930016S061 AMO Manufacturing USA, LLC	iDESIGN Refractive Studio	2020-02-14
PMA P930016S060 AMO Manufacturing USA, LLC	iDESIGN Refractive Studio	2020-01-28
PMA P930016S059 AMO Manufacturing USA, LLC	iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems	2019-05-28
PMA P930016S058 AMO Manufacturing USA, LLC	iDESIGN Refractive Studio	2019-05-03
PMA P990010S008 AMO Manufacturing USA, LLC	STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System	2019-04-12
PMA P930016S056 AMO Manufacturing USA, LLC	STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System	2019-04-12
PMA P910062S008 AMO Manufacturing USA, LLC	STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System	2019-04-12
PMA P930016S055 AMO Manufacturing USA, LLC	iDESIGN Refractive Studio; STAR Excimer Laser System	2019-01-29
PMN K182083 AMO Manufacturing USA, LLC	Catalys Precision Laser System	2018-11-09
PMA P930016S053 AMO Manufacturing USA, LLC	iDESIGNRefractive Studio, STAR Excimer Laser System	2018-06-15
PMA P930016S054 AMO Manufacturing USA, LLC	STAR Excimer Laser System	2018-02-09
PMN K172002 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Catalys Precision Laser System	2017-09-15
PMN K172002 AMO Manufacturing USA, LLC	Catalys Precision Laser System	2017-08-25
PMA P930016S051 AMO Manufacturing USA, LLC	Star S4 IR Excimer Laser System	2017-07-14
PMA P930016S048 AMO Manufacturing USA, LLC	STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System	2017-06-30
PMA P930016S052 AMO Manufacturing USA, LLC	Star S4 IR Excimer Laser System	2017-06-23
PMN K170322 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Catalys Precision Laser System	2017-06-15
PMA P930016S050 AMO Manufacturing USA, LLC	iDesign Advanced WaveScan Studio	2017-04-05
PMA P930016S049 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2017-01-11
PMN P930016 | LZS AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Excimer laser system	2016-12-22
PMN K161455 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Ophthalmic femtosecond laser	2016-12-22
PMN K151636 | HQC AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Unit, phacofragmentation	2016-12-22
PMN K141852 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K141852 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K141852 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K141852 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K141079 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Ophthalmic femtosecond laser	2016-12-22
PMN K133115 | HQC AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Unit, phacofragmentation	2016-12-22
PMN K121091 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Ophthalmic femtosecond laser	2016-12-22
PMN K113479 | OOE AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Ophthalmic femtosecond laser	2016-12-22
PMN K113151 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K113151 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K113151 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K113151 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K111697 | HQC AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Unit, phacofragmentation	2016-12-22
PMN K111446 | HQC AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Unit, phacofragmentation	2016-12-22
PMN K073404 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K073404 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K073404 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K073404 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K060372 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K060372 | HNO AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K060372 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Powered laser surgical instrument	2016-12-22
PMN K060372 | GEX AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Keratome, ac-powered	2016-12-22
PMN K060366 | HQC AMO Manufacturing USA, LLC [Johnson & Johnson Surgical Vision, Inc.]	Unit, phacofragmentation	2016-12-22
PMA P930016S045 AMO Manufacturing USA, LLC	IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM	2016-11-14
PMA P930016S047 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2016-02-09
PMA P930016S046 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2016-01-11
PMA P930016S044 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM	2015-05-06
PMN K141852 AMO MANUFACTURING USA, LLC	IFS ADVANCED FEMTOSECOND LASER SYSTEM	2015-01-06
PMA P990010S007 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2014-10-02
PMA P930016S043 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2014-10-02
PMA P910062S007 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM	2014-10-02
PMA P990010S006 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO	2014-05-30
PMA P990010S004 AMO Manufacturing USA, LLC	STAR, S41R EXCIMER LASER SYSTEM	2014-05-30
PMA P930016S042 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO	2014-05-30
PMA P930016S040 AMO Manufacturing USA, LLC	WAVESCAN WAVEFRONT SYSTEM	2014-05-30
PMA P910062S006 AMO Manufacturing USA, LLC	STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO	2014-05-30
PMA P910062S004 AMO Manufacturing USA, LLC	STAR S4 IM EXCIMER LASER SYSTEM	2014-05-30
PMA P930016S038 AMO Manufacturing USA, LLC	WAVESCAN WAVEFRONT SYSTEM	2013-06-27
PMA P930016S035 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)	2012-07-17
PMA P930016S036 AMO Manufacturing USA, LLC	STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM	2011-11-17
PMA P930016S034 AMO Manufacturing USA, LLC	WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68	2011-03-04
PMA P930016S032 AMO Manufacturing USA, LLC	STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)	2010-03-09
PMA P930016S031 AMO Manufacturing USA, LLC	VISX STAR S4 IR EXCIMER LASER SYSTEM	2008-12-01
PMA P930016S028 AMO Manufacturing USA, LLC	STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM	2008-04-09
PMA P930016S030 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM	2008-01-16
PMA P930016S027 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)	2007-11-09
PMA P930016S025 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM	2007-07-11
PMA P930016S026 AMO Manufacturing USA, LLC	VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM	2006-11-03
PMA P930016S024 AMO Manufacturing USA, LLC	VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM	2006-05-03
PMA P930016S023 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM	2005-09-28
PMA P930016S021 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM	2005-08-30
PMA P930016S022 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10	2005-05-02
PMA P930016S020 AMO Manufacturing USA, LLC	STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)	2005-03-17
PMA P930016S019 AMO Manufacturing USA, LLC	STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS	2005-02-18
PMA P930016S017 AMO Manufacturing USA, LLC	STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM	2004-12-14
PMA P930016S016 AMO Manufacturing USA, LLC	STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM	2003-05-23
PMA P930016S015 AMO Manufacturing USA, LLC	VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM	2002-08-07
PMA P930016S014 AMO Manufacturing USA, LLC	VISX STAR EXCIMER LASER SYSTEM	2001-11-06
PMA P930016S012 AMO Manufacturing USA, LLC	VISX STAR EXCIMER LASER SYSTEM	2001-04-27
PMA P930016S013 AMO Manufacturing USA, LLC	VISX STAR S2/S3 EXCIMER LASER SYSTEM	2001-03-19
PMA P930016S010 AMO Manufacturing USA, LLC	VISX STAR S2 AND S3 EXCIMER LASER SYSTEM	2000-10-18
PMA P990010S001 AMO Manufacturing USA, LLC	VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)	2000-04-20
PMA P930016S011 AMO Manufacturing USA, LLC	VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)	2000-04-20
PMA P910062S001 AMO Manufacturing USA, LLC	VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)	2000-04-20
PMA P990010 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODEL C STAR	1999-11-19
PMA P930016S007 AMO Manufacturing USA, LLC	VISX STAR S2 EXCIMER LASER SYSTEM	1998-11-02
PMA P930016S006 AMO Manufacturing USA, LLC	VISX STAR S2 EXCIMER LASER SYSTEM	1998-03-20
PMA P930016S005 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1998-01-29
PMA P930016S004 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1997-06-12
PMA P930016S003 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1997-04-24
PMA P930016S002 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1996-11-07
PMA P930016S001 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1996-10-15
PMA P930016 AMO Manufacturing USA, LLC	VISX EXCIMER LASER SYSTEM MODELS B AND C	1996-03-27
PMA P910062 AMO Manufacturing USA, LLC	VISX MODELB/MODEL C EXCIMER LASER SYSTEM	1995-09-29