NIDEK MULTICOLOR LASER PHOTOCOAGULATOR


Device Classification Name

laser, ophthalmic

510(k) Number K110228
Device Name NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
Applicant
NIDEK INCORPORATED
155-a moffett park drive
suite 210
sunnyvale, 
CA 
94089

Applicant Contact kit cariquitan
Correspondent
NIDEK INCORPORATED
155-a moffett park drive
suite 210
sunnyvale, 
CA 
94089

Correspodent Contact kit cariquitan
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 01/26/2011
Decision Date 02/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls