PMA P970053S010

Device: NIDEK EC-5000 EXCIMER LASER
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S010
Product code: LZS
Decision date: 2006-11-08
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL. THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII.

Current openFDA PMA Record#

Device: NIDEK EC-5000 EXCIMER LASER
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S010
Product code: LZS
Generic name: Excimer laser system
Decision date: 2006-11-08
Decision code: APPR
Date received: 2006-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL. THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII.