PMA P970053S014

Device: NIDEK EXCIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S014
Product code: LZS
Decision date: 2014-11-14
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR A NEW 200 HZ EYETRACKER, WHICH REPLACES THE EXISTING 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE IR ILLUMINATION.

Current openFDA PMA Record#

Device: NIDEK EXCIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S014
Product code: LZS
Generic name: Excimer laser system
Decision date: 2014-11-14
Decision code: APPR
Date received: 2014-08-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW 200 HZ EYETRACKER, WHICH REPLACES THE EXISTING 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE IR ILLUMINATION.