# Ulthera, Inc.

- Location (FDA's records): Mesa, AZ
- FDA decisions: 14 (2009–2026): 13 510(k) clearances and 1 De Novo grant
- Product codes: OHV (10), OUP (4)
- Predicates its devices cite: 15 (13 its own); citations of its devices by later devices: 17 (13 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cabochon Aesthetics, Inc.: 1 (https://510kreport.com/company/cabochon-aesthetics)
- Cortex Technology Aps: 1 (https://510kreport.com/company/cortex-technology)

## Firms that cite its devices most
- Sofwave Medical, Ltd.: 2 (https://510kreport.com/company/sofwave-medical)
- Nc8, Inc.: 1 (https://510kreport.com/company/nc8)
- Medicis Technologies Corporation: 1 (https://510kreport.com/company/medicis-technologies)

## Its most-cited devices
- DEN080006: Ulthera System, Model 8850-0001 (2009), cited by 3
- K180623: Ulthera System (2018), cited by 2
- K233996: Ulthera System (UC-1 Control Unit PRIME) (2024), cited by 2
- K134032: Ulthera System (2014), cited by 2
- K192185: The Cellfina System (2019), cited by 1
- K161885: The Cellfina System (2016), cited by 1

## Recent decisions
- K260618: Ulthera® System (May 21, 2026)
- K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1) (May 13, 2025)
- K243035: Ulthera® System (Feb 24, 2025)
- K233996: Ulthera System (UC-1 Control Unit PRIME) (Feb 22, 2024)
- K192185: The Cellfina System (Oct 9, 2019)
- K180623: Ulthera System (May 4, 2018)
- K161885: The Cellfina System (Oct 5, 2016)
- K153677: The Cellfina System (Feb 25, 2016)

Source page: https://510kreport.com/company/ulthera