# PSN: Light Based Imaging

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 85 days (middle half 85–176)
- 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)
- 2002: 1
- 2003: 1
- 2004: 1
- 2007: 1
- 2008: 1
- 2018: 1
- 2019: 1
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K023729: Siascope II (2003), cited by 2
- K040171: Microderm, Model/Version 3.5 (2004), cited by 2
- K192829: Demetra BDEM-01 Dermatoscope (2019), cited by 2
- K180162: VivaScope System (2018), cited by 1
- K062736: Siascope V (2007), cited by 1

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