PMA P930034S009

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S009
Product code: LZS
Decision date: 1998-03-11
Generic name: Excimer laser system
Approval order statement: Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis(R) disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(+- 1D) over the past year; and, 3) in patients who are 21 years of age or older.

Current openFDA PMA Record

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S009
Product code: LZS
Generic name: Excimer laser system
Decision date: 1998-03-11
Decision code: APPR
Date received: 1997-04-02
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) disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(+- 1D) over the past year; and, 3) in patients who are 21 years of age or older.