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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 K153229
Device Name Superbium
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  
Subsequent Product Codes
ONF   ONG  
Date Received11/06/2015
Decision Date 04/12/2016
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
Predetermined Change
Control Plan Authorized		 No
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