FDA 510(k) Application Details - K081324

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K081324
Device Name	Powered Laser Surgical Instrument
Applicant	CANDELA CORP. 530 BOSTON POST ROAD WAYLAND, MA 01778 US Other 510(k) Applications for this Company
Contact	LISA LACROIX Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2008
Decision Date	06/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review