# OLI: Fat Reducing Low Level Laser

- Device class: 2; regulation: 21 CFR 878.5400; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 76 days (middle half 53–124)
- 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: 3
- 2016: 2
- 2017: 2
- 2018: 1
- 2020: 3
- 2021: 1
- 2022: 2
- 2023: 2
- 2025: 3
- 2026: 3

## Most-cited predicates
- K160880: Photonica Professional (2016), cited by 5
- K202955: Contour Light CL-100 (2021), cited by 4
- K232977: Biophotas Celluma CONTOUR (2023), cited by 4
- K130341: Strawberry, Strawberry & Cream (2013), cited by 4
- K192544: Erchonia Emerald (2020), cited by 3
- K111501: I-Lipo System (2012), cited by 2
- K143741: Lipofina Laser System (2015), cited by 2
- K180338: Cellulize (2018), cited by 2
- K162578: Zerona Z6 OTC (2016), cited by 2
- DEN090008: Erchonia ML Scanner (MLS) (2010), cited by 2

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