PMA P930034S003

Device: SVS APEX APEX EXIMER LASER WORKSTATION
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S003
Product code: LZS
Decision date: 1996-11-25
Generic name: Excimer laser system
Approval order statement: ALL LABELING MUST CONTAIN THE FOLLOWING PRECAUTION STATEMENT: PRECAUTION: ALTHOUGH THE EFFECTS OF PRK ON VISUAL PERFORMANCE UNDER POOR LIGHTING CONDITIONS HAVE NOT BEEN DETERMINED, IT IS POSSIBLE THAT YOU WILL FIND IT MORE DIFFICULT THAN USUAL TO SEE IN CONDITIONS SUCH AS VERY DIM LIGHT, RAIN, SNOW, FOG, OR GLARE FROM BRIGHT LIGHTS AT NIGHT.

Current openFDA PMA Record

Device: SVS APEX APEX EXIMER LASER WORKSTATION
Applicant: Alcon Laboratories, Inc.
PMA number: P930034
Supplement: S003
Product code: LZS
Generic name: Excimer laser system
Decision date: 1996-11-25
Decision code: APPR
Date received: 1996-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Other
Approval order statement: ALL LABELING MUST CONTAIN THE FOLLOWING PRECAUTION STATEMENT: PRECAUTION: ALTHOUGH THE EFFECTS OF PRK ON VISUAL PERFORMANCE UNDER POOR LIGHTING CONDITIONS HAVE NOT BEEN DETERMINED, IT IS POSSIBLE THAT YOU WILL FIND IT MORE DIFFICULT THAN USUAL TO SEE IN CONDITIONS SUCH AS VERY DIM LIGHT, RAIN, SNOW, FOG, OR GLARE FROM BRIGHT LIGHTS AT NIGHT.