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AMO Manufacturing USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066958643006695864AMO Manufacturing USA, LLC1N2026-01-01510 Cottonwood Drive Milpitas CA US 95035

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2027761622246011P930016VISX EXCIMER LASER SYSTEM MODELS B AND CLZS1996-03-27
2027761812834734K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceOOE2023-04-14
2027761327910768K220516CATALYS Precision Laser systemOOE2022-05-17
2027761281944434K210701CATALYS Precision Laser SystemOOE2021-04-07
2027761000670424K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlHQC2021-03-12
2027761051002609K200056Catalys Precision Laser SystemOOE2020-05-18
2027761788740110K182083Catalys Precision Laser SystemOOE2018-11-09
2027761826305162K172002Catalys Precision Laser SystemOOE2017-08-25
2027761589756831K170322Catalys Precision Laser SystemOOE2017-05-19
2027761862999233K170322Catalys Precision Laser SystemOOE2017-05-19
2027761692923189K161455Catalys Precision Laser SystemOOE2016-09-20
2027761291926804K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote ControlHQC2015-10-19
2027761970931574K141852IFS ADVANCED FEMTOSECOND LASER SYSTEMGEX2015-01-06
2027761835231038K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2014-09-11
2027761213958742K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACKHQC2014-02-27
2027761126082280K121091CATALYS PRECISION LASER SYSTEMOOE2012-08-28
2027761490834348K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMOOE2011-12-21
2027761787575465K113151IFS LASER SYSTEMGEX2012-03-08
2027761812911567K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEMHQC2011-09-27
2027761011033539K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEMHQC2011-12-21
2027761376809004K073404IFS LASER SYSTEMGEX2008-04-25
2027761802087151K060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3GEX2006-08-16
2027761391407475K060366THE AMO OPHTHALMIC SURGICAL SYSTEMHQC2006-04-07
2027761676189096K041893INTRALASE FS LASERGEX2005-07-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OOE122023-04-14
HQC62021-03-12
GEX52015-01-06
LZS11996-03-27

PMA#

66 records. Showing 1-40. Next

PMN#