PDE PHOTODYNAMIC EYE


Device Classification Name

confocal optical imaging

510(k) Number K110480
Device Name PDE PHOTODYNAMIC EYE
Applicant
HAMAMATSU PHOTONICS, K.K.
700 13th street, nw suite 1200
washington, 
DC 
20005

Applicant Contact jeffrey k shapiro
Correspondent
HAMAMATSU PHOTONICS, K.K.
700 13th street, nw suite 1200
washington, 
DC 
20005

Correspodent Contact jeffrey k shapiro
Regulation Number 876.1500
Classification Product Code
OWN  
Date Received 02/18/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes