PMA P930016S026

Device: VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S026
Product code: LZS
Decision date: 2006-11-03
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR AN UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS.

Current openFDA PMA Record#

Device: VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S026
Product code: LZS
Generic name: Excimer laser system
Decision date: 2006-11-03
Decision code: APPR
Date received: 2006-10-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS.