PMA P970043S004

Device: LADAR VISION TREATMENTS
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S004
Product code: LZS
Decision date: 1999-09-24
Generic name: Excimer laser system
Approval order statement: Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.

Current openFDA PMA Record

Device: LADAR VISION TREATMENTS
Applicant: Alcon Laboratories
PMA number: P970043
Supplement: S004
Product code: LZS
Generic name: Excimer laser system
Decision date: 1999-09-24
Decision code: APPR
Date received: 1999-08-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.