STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO

Excimer Laser System

FDA Premarket Approval P990010 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Addition of a re-polishing process for the hex prism assembly, of the star system.

DeviceSTAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantAMO Manufacturing USA, LLC
Date Received2014-05-19
Decision Date2014-05-30
PMAP990010
SupplementS006
Product CodeLZS
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035

Supplemental Filings

Supplement NumberDateSupplement Type
P990010Original Filing
S008 2018-12-31 Real-time Process
S007 2014-07-07 Real-time Process
S006 2014-05-19 30-day Notice
S005
S004 2014-05-01 30-day Notice
S003
S002
S001 2000-04-12 Real-time Process

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