PMA P930034S012

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S012
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, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK.

Current openFDA PMA Record

Device: SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S012
Product code: LZS
Generic name: Excimer laser system
Decision date: 1999-10-21
Decision code: APPR
Date received: 1998-07-14
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, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK.