PMA P030008S009

Device: WAVELIGHT EX500 EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S009
Product code: LZS
Decision date: 2013-11-25
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.

Current openFDA PMA Record#

Device: WAVELIGHT EX500 EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S009
Product code: LZS
Generic name: Excimer laser system
Decision date: 2013-11-25
Decision code: APPR
Date received: 2012-11-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.