PMA P990027S016

Device: TECHNOLAS 217Z ZYOPTIX SYSTEM
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S016
Product code: LZS
Decision date: 2011-01-26
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR 1) A SINGLE PART HARD DISK DRIVE; 2) AN ADDITIONAL CALIBRATION TOOL; 3) CHANGE THE SPUTTER PROCESS OF THE APERTURE; AND 4) PRODUCTION OF THE HIGH PRESSURE UNIT AND ASSOCIATED TESTING OUTSOURCED TO A NEW SUPPLIER.

Current openFDA PMA Record#

Device: TECHNOLAS 217Z ZYOPTIX SYSTEM
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S016
Product code: LZS
Generic name: Excimer laser system
Decision date: 2011-01-26
Decision code: APPR
Date received: 2010-09-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR 1) A SINGLE PART HARD DISK DRIVE; 2) AN ADDITIONAL CALIBRATION TOOL; 3) CHANGE THE SPUTTER PROCESS OF THE APERTURE; AND 4) PRODUCTION OF THE HIGH PRESSURE UNIT AND ASSOCIATED TESTING OUTSOURCED TO A NEW SUPPLIER.