PMA P930034S013

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S013
Product code: LZS
Decision date: 1999-10-21
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.

Current openFDA PMA Record

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S013
Product code: LZS
Generic name: Excimer laser system
Decision date: 1999-10-21
Decision code: APPR
Date received: 1999-02-11
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.