K-number	DEN150005
Device name	Newa Skin Therapy System
Applicant	Endymed Medical, Ltd.
Product code	PAY
Device class	Class II
Decision date	Dec 18, 2015
Decision	Not Substantially Equivalent
Regulation	878.4420

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View the full FDA submission: accessdata.fda.gov

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Newa Skin Therapy System

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