# DEN150005: Newa Skin Therapy System

- Pathway: De Novo (Direct)
- Applicant: Endymed Medical, Ltd.
- Decided: Dec 18, 2015 after 336 days
- Product code: PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K182774: STOP U (Packed Black USA), STOP U (Packed White USA) (2019), 5 descendants of its own
- K203665: STOP U Model UXV Device (2021), 4 descendants of its own
- K220322: Pollogen STOP U Model UXV Device (2023), 3 descendants of its own
- K170499: sensiLift (2017), 1 descendant of its own
- K162784: Silk'n HST (2017), 1 descendant of its own

## Indications for use
The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women with Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/DEN150005
Methodology: https://510kreport.com/methodology