# K191421: Sofacia System

- Pathway: 510(k) (Traditional)
- Applicant: Sofwave Medical, Ltd.
- Decided: Sep 9, 2019 after 104 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: 4 generations back to K894834 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134032: Ulthera System, Ulthera, Inc. (2014) Summary page 4.

## Indications for use
The Sofacia System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

Source page: https://510kreport.com/device/K191421
Methodology: https://510kreport.com/methodology