# Sonacare Medical, LLC

- Location (FDA's records): Charlotte, NC
- FDA decisions: 2 (2015–2016): 1 510(k) clearance and 1 De Novo grant
- Product codes: PLP (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Edap Technomed, Inc.: 3 (https://510kreport.com/company/edap-technomed)
- Insightec, Ltd.: 1 (https://510kreport.com/company/insightec)

## Its most-cited devices
- K160942: Sonablate (2016), cited by 3
- DEN150011: Sonablate 450 (2015), cited by 1

## Recent decisions
- K160942: Sonablate (Dec 21, 2016)
- DEN150011: Sonablate 450 (Oct 9, 2015)

Source page: https://510kreport.com/company/sonacare-medical