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510(k) DEN150005

Newa Skin Therapy System by Endymed Medical, Ltd. — Product Code PAY

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 18, 2015
Date Received
January 16, 2015
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4420
Review Panel
SU
Submission Type

An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

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