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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K131567
Device Name ALADDIN
Applicant
VISIA imaging S.r.l.
110 EAST GRANADA BLVD, STE 209
ORMOND BEACH,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
VISIA imaging S.r.l.
110 EAST GRANADA BLVD, STE 209
ORMOND BEACH,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number886.1850
Classification Product Code
HJO  
Date Received05/30/2013
Decision Date 06/05/2014
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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