FDA 510(k) Application Details - K072344

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K072344
Device Name Powered Laser Surgical Instrument
Applicant BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
VIMODRONE (MILAN) I-20090 IT
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Contact ALDO CASALINO
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 08/21/2007
Decision Date 12/03/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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