# NHN: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

- Device class: 2; regulation: 21 CFR 890.5500; FDA's rule: 510(k) required
- FDA decisions: 54
- 510(k) review time 2021–2025: median 185 days (middle half 88–416)
- Recalls: 2 (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: 1
- 2016: 3
- 2018: 3
- 2019: 2
- 2021: 2
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K010175: Microlight 830 Laser System (2002), cited by 11
- K012580: Erchonia PL2000 (2002), cited by 5
- K020657: Acculaser Pro Low Level Laser Therapy Device (2002), cited by 5
- K030226: Thor Ddii 830CL3 Laser System (2003), cited by 4
- K032816: Quantum Light Therapy System (2004), cited by 4
- K021985: Medx LCS Laser Series (2002), cited by 3
- K041530: Excalibur Light Therapy System, Model Sgiex-04-001 (2004), cited by 3
- K030692: Power Laser 90 (2003), cited by 3
- K132940: Erchonia Allay (2014), cited by 2
- K191257: Erchonia EVRL (2019), cited by 2

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