FDA 510(k) Application Details - K150752

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K150752
Device Name	Light, Ultraviolet, Dermatological
Applicant	GME (GERMAN MEDICAL ENGINEERING) GMBH GRIMMSTRASSE 23 NUERENBERG, BAVARIA 90491 DE Other 510(k) Applications for this Company
Contact	STEFAN SCHULZE Other 510(k) Applications for this Contact
Regulation Number	878.4630   More FDA Info for this Regulation Number
Classification Product Code	FTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2015
Decision Date	07/31/2015
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