PMA P030008S013

Device: WAVELIGHT EX500 EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S013
Product code: LZS
Decision date: 2014-04-10
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).

Current openFDA PMA Record#

Device: WAVELIGHT EX500 EXCIMER LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S013
Product code: LZS
Generic name: Excimer laser system
Decision date: 2014-04-10
Decision code: APPR
Date received: 2014-01-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).