NIDEK EXCLAIMER LASER SYSTEM EC-5000

FDA premarket approval P970053/S015 · decided 2015-03-30

Approval details

PMA number

P970053

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

NIDEK EXCLAIMER LASER SYSTEM EC-5000

Generic name

Excimer laser system

Applicant

Nidek Co., Ltd.

Date received

2014-10-03

Decision date

2015-03-30

Days to decision

178 days

Decision code

APPR

Product code

LZS

Advisory committee

Ophthalmic

Expedited review

No

Location

Gamagori

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

510(k) clearances by this applicant