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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 K043521
Device Name BIOSYAG 50 MED
Applicant
Bios S.R.L.
16 Indian Spring Dr.
Silver Spring,  MD  20901
Applicant Contact ALESSANDRO FRANCHI ONDE
Correspondent
Bios S.R.L.
16 Indian Spring Dr.
Silver Spring,  MD  20901
Correspondent Contact ALESSANDRO FRANCHI ONDE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/20/2004
Decision Date 03/24/2005
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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