PMA P970053S013

Device: NIDEK EXCIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S013
Product code: LZS
Decision date: 2014-11-21
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL TO USE THE OPD-SCAN III ABERROMETER AND UPDATE THE FINAL FIT SOFTWARE (V1.11 TO 1.12) TO FACILITATE COMPATIBILITY WITH A NEW ABERROMETER TO PERFORM TOPOGRAPHY-GUIDED LASER IN-SITU KERATOMILEUSIS (LASIK).

Current openFDA PMA Record#

Device: NIDEK EXCIMER LASER SYSTEM EC-5000
Applicant: Nidek Co., Ltd.
PMA number: P970053
Supplement: S013
Product code: LZS
Generic name: Excimer laser system
Decision date: 2014-11-21
Decision code: APPR
Date received: 2014-02-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO USE THE OPD-SCAN III ABERROMETER AND UPDATE THE FINAL FIT SOFTWARE (V1.11 TO 1.12) TO FACILITATE COMPATIBILITY WITH A NEW ABERROMETER TO PERFORM TOPOGRAPHY-GUIDED LASER IN-SITU KERATOMILEUSIS (LASIK).