FDA 510(k) Application Details - K123682

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K123682
Device Name	Powered Laser Surgical Instrument
Applicant	INMODE MD LTD. 20 HATA'AS STR., SUITE 102 KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	11/30/2012
Decision Date	02/27/2013
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