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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 St.
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 St.
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
Predetermined Change
Control Plan Authorized		 No
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