# LLO: Laser, Neodymium:Yag, Pulmonary Surgery

- Device class: 2; regulation: 21 CFR 874.4500; FDA's rule: 510(k) required
- FDA decisions: 19
- 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)
- 1985: 4
- 1986: 5
- 1987: 3
- 1988: 7

## Most-cited predicates

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