# OOE: Ophthalmic Femtosecond Laser

- Device class: 2; regulation: 21 CFR 886.4390; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 120 days (middle half 70–132)
- Recalls: 3 (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)
- 2014: 4
- 2015: 5
- 2016: 2
- 2017: 6
- 2018: 5
- 2020: 2
- 2021: 1
- 2022: 3
- 2023: 2
- 2025: 2

## Most-cited predicates
- K101626: Lensx Laser System (2010), cited by 7
- K082947: Lensx 550 Laser System (2009), cited by 7
- K141476: Wavelight FS200 Laser System (2014), cited by 4
- K094052: Lensx 550 Laser System. Model 550 (2010), cited by 4
- K090633: Lensar Laser System (2010), cited by 4
- K132534: Victus Femtosecond Laser Platform (2014), cited by 3
- K102727: Lensar Laser System for Anterior Capsulotomy (2011), cited by 3
- K112098: TBD (2011), cited by 2
- K120214: TBD (2012), cited by 2
- K122386: Victus Femtosecond Laser Platform (2013), cited by 2

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