PMA P980008S009

Device: LASERSCAN LSX EXCIMER LASER SYSTEM
Applicant: Lasersight Technologies, Inc.
PMA number: P980008
Supplement: S009
Product code: LZS
Decision date: 2001-11-09
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.

Current openFDA PMA Record#

Device: LASERSCAN LSX EXCIMER LASER SYSTEM
Applicant: Lasersight Technologies, Inc.
PMA number: P980008
Supplement: S009
Product code: LZS
Generic name: Excimer laser system
Decision date: 2001-11-09
Decision code: APPR
Date received: 2001-10-26
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.