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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact PAULO ANEAS LICHTI
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/26/2011
Decision Date 08/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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