EASYSCAN MODEL 1.2


Device Classification Name

ophthalmoscope,laser,scanning

510(k) Number K111988
Device Name EASYSCAN MODEL 1.2
Applicant
I-OPTICS BV
220 river road
claremont, 
NH 
03743

Applicant Contact william greenrose
Correspondent
I-OPTICS BV
220 river road
claremont, 
NH 
03743

Correspodent Contact william greenrose
Regulation Number 886.1570
Classification Product Code
MYC  
Date Received 07/13/2011
Decision Date 10/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No