FDA 510(k) Application Details - K112524

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K112524
Device Name	Laser, Comb, Hair
Applicant	LEXINGTON INTERNATIONAL, LLC 777 YAMATO RD., SUITE 105 BOCA RATON, FL 33431 US Other 510(k) Applications for this Company
Contact	DAVID MICHAELS Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2011
Decision Date	09/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review