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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 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
Correspondent Contact PAULO ANEAS LICHTI
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/13/2011
Decision Date 11/03/2011
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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