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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 K161632
Device Name FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
Applicant
BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
vimodrone,  IT i-20090
Applicant Contact riccardo pisati
Correspondent
BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
vimodrone,  IT i-20090
Correspondent Contact riccardo pisati
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/13/2016
Decision Date 12/08/2016
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
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