NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI


Device Classification Name

laser, ophthalmic

510(k) Number K111493
Device Name NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Applicant
NIDEK CO., LTD.
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Applicant Contact michael j billig
Correspondent
NIDEK CO., LTD.
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Correspodent Contact michael j billig
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 05/31/2011
Decision Date 07/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No