Not Cleared Direct

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

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150005 · Endymed Medical, Ltd. · General & Plastic Surgery device
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Dec 2015
Decision
336d
Days
Class 2
Risk

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.

View all Endymed Medical, Ltd. devices

Submission Details

510(k) Number DEN150005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 16, 2015
Decision Date December 18, 2015
Days to Decision 336 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 115d · This submission: 336d
Pathway characteristics

Device Classification

Product Code PAY Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4420
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.