PMA P030008S012

Device: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S012
Product code: LZS
Decision date: 2013-10-18
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.

Current openFDA PMA Record#

Device: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S012
Product code: LZS
Generic name: Excimer laser system
Decision date: 2013-10-18
Decision code: APPR
Date received: 2013-07-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.