FDA 510(k) Application Details - K100590

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K100590
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	JM SYSTEM CO., LTD. 410 DAERUNG TECHNO TOWN 8TH GASAN-DONG GEUMCHEN-GU, SEOUL, 153-77 KR Other 510(k) Applications for this Company
Contact	SU-GUN LEE 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	03/02/2010
Decision Date	11/10/2010
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