# OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

- Device class: 2; regulation: 21 CFR 878.4590; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 89 days (middle half 70–122)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 3
- 2017: 1
- 2018: 1
- 2019: 2
- 2021: 1
- 2022: 1
- 2023: 7
- 2024: 2
- 2025: 2
- 2026: 1

## Most-cited predicates
- K141708: Ultrashape System (2014), cited by 4
- DEN080006: Ulthera System, Model 8850-0001 (2009), cited by 3
- K112626: Lipsonix (R) System Model 2 (2011), cited by 3
- K180623: Ulthera System (2018), cited by 2
- K134032: Ulthera System (2014), cited by 2
- K233996: Ulthera System (UC-1 Control Unit PRIME) (2024), cited by 2
- K160896: Ultrashape Power System (2016), cited by 2
- K133238: Contour I V3.1 System (2014), cited by 2
- K230019: SofWave System (2023), cited by 1
- K231537: SofWave System (2023), cited by 1

Source page: https://510kreport.com/product-code/OHV
Data by year (CSV): https://510kreport.com/product-code/OHV.csv