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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K170718
Device Name Iridex TruFocus LIO Premiere
Applicant
Iridex Corporation
1212 Terra Bella Avenue
Mountain View,  CA  94043 -1824
Applicant Contact Gloria Dy
Correspondent
Iridex Corporation
1212 Terra Bella Avenue
Mountain View,  CA  94043 -1824
Correspondent Contact Gloria Dy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/09/2017
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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