STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Premarket Approval P990010 S007

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

Approval for redesign of the star thyratron trigger board(p/n 0040-0044).

DeviceSTAR EXCIMER LASER SYSTEM
Classification NameExcimer Laser System
Generic NameExcimer Laser System
ApplicantAMO Manufacturing USA, LLC
Date Received2014-07-07
Decision Date2014-10-02
PMAP990010
SupplementS007
Product CodeLZS
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.