510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150005Unknown

Newa Skin Therapy System

Endymed Medical Inc., Caesarea, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN150005 is the FDA 510(k) clearance record for Newa Skin Therapy System, a class II device, cleared for Endymed Medical, Ltd. on under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction). FDA's definition for product code PAY reads: "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". FDA records list 8 510(k) clearances for Endymed Medical, Ltd., from to . As of , FDA records show no recalls naming DEN150005.

Clearance record

Decision date
Received
(336 days to decision)
Product code
PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Endymed Medical, Ltd. 12 Leshem St., N. Industrial Park, Caesarea, IL
Third party review
No

Clearances, product code PAY

Trailing 12 months
1 clearance under product code PAY in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260