# PKT: Laser For Disruption Of Adipocyte Cells For Aesthetic Use

- Device class: 2; regulation: 21 CFR 878.5400; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 85 days (middle half 66–123)
- Recalls: 0 (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)
- 2015: 2
- 2016: 1
- 2017: 2
- 2019: 3
- 2020: 2
- 2021: 2
- 2022: 2
- 2023: 3
- 2024: 2

## Most-cited predicates
- K191068: Powersculp laser lipolysis system (2019), cited by 4
- K160470: SculpSure (2016), cited by 4
- K171992: SculpSure (2017), cited by 3
- K182741: SculpSure (2019), cited by 3
- K171111: Sculpsure (2017), cited by 2
- K150230: SculpSure (2015), cited by 2
- K211681: EON (2022), cited by 1
- K212331: BodySculp (2021), cited by 1
- K150724: SculpSure (2015), cited by 1
- K201731: Diode Laser Body Sculpture System (2020), cited by 1

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