DEN150005 - Newa Skin Therapy System (FDA 510(k) Clearance)

DEN150005 is an FDA 510(k) submission (not cleared) for the Newa Skin Therapy System. Classified as Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (product code PAY), Class II - Special Controls.

Submitted by Endymed Medical, Ltd. (Caesarea, IL). The FDA issued a Not Cleared (DENG) decision on December 18, 2015 after a review of 336 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4420 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 336 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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