OPTO HYALUS GREEN LASER


Device Classification Name

laser, ophthalmic

510(k) Number K111460
Device Name OPTO HYALUS GREEN LASER
Applicant
OPTO ELETRONICA S/A
joaquim a. r. de souza street
1071-jardim santa felicia
sao carlos, sao paulo, 

BR

13630-330

Applicant Contact paulo aneas lichti
Correspondent
OPTO ELETRONICA S/A
joaquim a. r. de souza street
1071-jardim santa felicia
sao carlos, sao paulo, 

BR

13630-330

Correspodent Contact paulo aneas lichti
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 05/26/2011
Decision Date 08/20/2012
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