PMA P970053S003

Device: EC-5000 EXCIMER LASER SYSTEM
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S003
Product code: LZS
Decision date: 2000-10-25
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE INCORPORATION OF THE NOMOGRAM FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS INTO THE NIDEK EC-5000 SOFTWARE, ALONG WITH THE NOMOGRAM FOR PRK FOR MODERATE MYOPIA WITH ASTIGMATISM.

Current openFDA PMA Record#

Device: EC-5000 EXCIMER LASER SYSTEM
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S003
Product code: LZS
Generic name: Excimer laser system
Decision date: 2000-10-25
Decision code: APPR
Date received: 2000-04-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE INCORPORATION OF THE NOMOGRAM FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS INTO THE NIDEK EC-5000 SOFTWARE, ALONG WITH THE NOMOGRAM FOR PRK FOR MODERATE MYOPIA WITH ASTIGMATISM.