FDA 510(k) Application Details - K093963

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K093963
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	SILVER BAY, LLC 1431 Tallevast Road Sarasota, FL 34243 US Other 510(k) Applications for this Company
Contact	PETER NESBITT Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2009
Decision Date	08/27/2010
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