PMA P030008S010

Device: WAVELIGHT EX 500 LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S010
Product code: LZS
Decision date: 2013-04-12
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL TO INTRODUCE THE WAVENET¿ NETWORK SYSTEM TO FACILITATE DATA EXCHANGE BETWEEN FDA APPROVED/ CLEARED WAVELIGHT® REFRACTIVE/ THERAPEUTIC AND DIAGNOSTIC DEVICES VIA A NETWORK SERVER.

Current openFDA PMA Record#

Device: WAVELIGHT EX 500 LASER SYSTEM
Applicant: Alcon Laboratories, Inc.
PMA number: P030008
Supplement: S010
Product code: LZS
Generic name: Excimer laser system
Decision date: 2013-04-12
Decision code: APPR
Date received: 2013-01-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO INTRODUCE THE WAVENET¿ NETWORK SYSTEM TO FACILITATE DATA EXCHANGE BETWEEN FDA APPROVED/ CLEARED WAVELIGHT® REFRACTIVE/ THERAPEUTIC AND DIAGNOSTIC DEVICES VIA A NETWORK SERVER.