PMA P960019S002

Device: LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Applicant: Laser Vision Centers, Inc.
PMA number: P960019
Supplement: S002
Product code: LZS
Decision date: 1998-05-05
Generic name: Excimer laser system
Approval order statement: Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK. The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.

Current openFDA PMA Record#

Device: LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Applicant: Laser Vision Centers, Inc.
PMA number: P960019
Supplement: S002
Product code: LZS
Generic name: Excimer laser system
Decision date: 1998-05-05
Decision code: APPR
Date received: 1998-04-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK. The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.