# ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 74
- 510(k) review time 2021–2025: median 121 days (middle half 86–197)
- 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)
- 2016: 5
- 2018: 2
- 2019: 2
- 2020: 4
- 2021: 4
- 2022: 4
- 2023: 5
- 2024: 5
- 2025: 4
- 2026: 1

## Most-cited predicates
- K122995: Intense Pulsed Light (Ipl) Systems (2013), cited by 7
- K103560: Shaser Ipl Hair Removal System (2011), cited by 5
- K161565: DUO (2016), cited by 4
- K093627: Ipulselight Ipl System, Models HS 300C and HS 650 (2011), cited by 4
- K161286: IPL Therapy Machine (2016), cited by 3
- K200746: IPL Treatment Systems (2020), cited by 3
- K140631: Lumena FH Hair Removal System (2014), cited by 3
- K120080: Shaser HRS2 Hair Removal System (2012), cited by 3
- K141237: Harmony Lite (2015), cited by 2
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), cited by 2

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