# K232455: SofWave System

- Pathway: 510(k) (Traditional)
- Applicant: Sofwave Medical, Ltd.
- Decided: Dec 14, 2023 after 122 days
- Product code: OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption)
- Device class: 2
- Regulation: 21 CFR 878.4590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894834 (1989). 18 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230820: SofWave System, Sofwave Medical, Ltd. (2023) Summary page 5.
- K212866: truSculpt flex, Johari Digital Healthcare Limited (2022) Summary page 5.

## Most influential descendants
- K240687: SofWave System (2024), 3 descendants of its own
- K241685: SofWave System (2024), 2 descendants of its own
- 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. • Strengthening, toning and firming of buttocks and thighs.

Source page: https://510kreport.com/device/K232455
Methodology: https://510kreport.com/methodology