# K130793: Newa Skin Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Endymion Medical, Ltd.
- Decided: Aug 16, 2013 after 147 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 199 ancestors in all.
No later device cites it as a predicate yet.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 1.
- K090525: Loi System, Palomar Medical Products, Inc. (2009) Summary page 1.

## Indications for use
The EndyMed Newa™ is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides

Source page: https://510kreport.com/device/K130793
Methodology: https://510kreport.com/methodology