# MUW: Lens, Contact (Orthokeratology)

- Device class: 2; regulation: 21 CFR 886.5916; FDA's rule: 510(k) 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)
- 1998: 1
- 2000: 1
- 2001: 2
- 2004: 1
- 2005: 1
- 2016: 1
- 2019: 1

## Most-cited predicates
- K003933: Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy (2001), cited by 1
- K973697: Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear Orthokeratology (1998), cited by 1

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