PMA P970053S015

Device: NIDEK EXCLAIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S015
Product code: LZS
Decision date: 2015-03-30
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE A NEW 1 KHZ EYETRACKER, WHICH REPLACES THE ORIGINAL 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 INFRARED RED (IR) ILLUMINATION. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO - 4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +=0.5 D.

Current openFDA PMA Record#

Device: NIDEK EXCLAIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S015
Product code: LZS
Generic name: Excimer laser system
Decision date: 2015-03-30
Decision code: APPR
Date received: 2014-10-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE A NEW 1 KHZ EYETRACKER, WHICH REPLACES THE ORIGINAL 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 INFRARED RED (IR) ILLUMINATION. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO - 4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +=0.5 D.