PMA P930016S063

Current openFDA PMA Record

Device: iDesign Refractive Studio
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S063
Product code: LZS
Generic name: Excimer laser system
Decision date: 2023-10-16
Decision code: OK30
Date received: 2023-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: new suppliers for cable and mounting arm components of the iDESIGN