# K211483: SofWave System

- Pathway: 510(k) (Traditional)
- Applicant: Sofwave Medical, Ltd.
- Decided: Nov 15, 2021 after 187 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: 5 generations back to K894834 (1989). 7 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180623: Ulthera System, Ulthera, Inc. (2018) Summary page 4.

## Most influential descendants
- K223237: SofWave System (2022), 7 descendants of its own
- K230019: SofWave System (2023), 6 descendants of its own
- K230820: SofWave System (2023), 5 descendants of its own
- K232455: SofWave System (2023), 4 descendants of its own
- K240687: SofWave System (2024), 3 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 regions for subjects aged 22 and older.

Source page: https://510kreport.com/device/K211483
Methodology: https://510kreport.com/methodology