PMA P930016S049

Device: STAR EXCIMER LASER SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S049
Product code: LZS
Decision date: 2017-01-11
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: Revision of the span and zero calibration procedure of the fluorine (F2) sensor of the STAR S4 IR Excimer Laser System according to the sensor’s manufacturer specification.

Current openFDA PMA Record#

Device: STAR EXCIMER LASER SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S049
Product code: LZS
Generic name: Excimer laser system
Decision date: 2017-01-11
Decision code: OK30
Date received: 2016-12-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Revision of the span and zero calibration procedure of the fluorine (F2) sensor of the STAR S4 IR Excimer Laser System according to the sensor’s manufacturer specification.