# K250146: SofWave System

- Pathway: 510(k) (Traditional)
- Applicant: Sofwave Medical, Ltd.
- Decided: Apr 18, 2025 after 87 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: 12 generations back to K903402 (1990). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241685: SofWave System, Sofwave Medical, Ltd. (2024) Summary page 5.
- K233104: SofWave System, Sofwave Medical, Ltd. (2023) Summary page 5.
- K221200: XBody Go USA, XBody Pro USA, Xbody Hungary Kft. (2023) Summary page 5.

## Most influential descendants
- 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 intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms. 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. * The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K250146
Methodology: https://510kreport.com/methodology