# K241685: SofWave System

- Pathway: 510(k) (Traditional)
- Applicant: Sofwave Medical, Ltd.
- Decided: Aug 7, 2024 after 57 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K903402 (1990). 53 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240687: SofWave System, Sofwave Medical, Ltd. (2024) Summary page 5.
- K233926: accufit, Mettler Electronics Corporation (2024) Summary page 5.

## Most influential descendants
- K250146: SofWave System (2025), 1 descendant of its own
- K251746: Pure Impact (2025), 0 descendants of its own

## Indications for use
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite. The Pure Impact module is indicated to be used for: * Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. * Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

Source page: https://510kreport.com/device/K241685
Methodology: https://510kreport.com/methodology