FDA 510(k) Application Details - K111831

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K111831
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	BIO-MED U.S.A., INC. 111 ELLISON ST. PATERSON, NJ 07505 US Other 510(k) Applications for this Company
Contact	YOUNG CHI Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2011
Decision Date	12/19/2011
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