OPTO MITRA YELLOW LASER


Device Classification Name

laser, ophthalmic

510(k) Number K111643
Device Name OPTO MITRA YELLOW LASER
Applicant
OPTO ELECTRONICA SA
joaquim a.r. de souza st.
1071 – jardim santa felicia
sao carlos, sao paulo, 

BR

13.563-330

Applicant Contact paulo aneas lichti
Correspondent
OPTO ELECTRONICA SA
joaquim a.r. de souza st.
1071 – jardim santa felicia
sao carlos, sao paulo, 

BR

13.563-330

Correspodent Contact paulo aneas lichti
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 06/13/2011
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No