# MWL: Lens, Contact (Rigid Gas Permeable), Extended Wear

- Device class: 3; regulation: 21 CFR 886.5916; FDA's rule: PMA required
- FDA decisions: 6
- 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)
- 2011: 2
- 2014: 2
- 2016: 1
- 2019: 2
- 2020: 4
- 2021: 1
- 2022: 4
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- P870024: Fluoroperm RGP Contact Lenses (1987), cited by 4
- P860022: Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens (1987), cited by 3

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