# LPL: Lenses, Soft Contact, Daily Wear

- Device class: 2; regulation: 21 CFR 886.5925; FDA's rule: 510(k) required
- FDA decisions: 497
- 510(k) review time 2021–2025: median 160 days (middle half 58–245)
- Recalls: 41 (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)
- 2017: 9
- 2018: 21
- 2019: 11
- 2020: 10
- 2021: 8
- 2022: 9
- 2023: 10
- 2024: 12
- 2025: 12
- 2026: 10

## Most-cited predicates
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), cited by 15
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker (1996), cited by 12
- K100221: INTELLIWAVE3 (2010), cited by 11
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint (1997), cited by 11
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs (2004), cited by 10
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses (2008), cited by 9
- K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color) (2001), cited by 7
- K983637: Actifresh 400 Lens (1999), cited by 7
- K051095: 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (2005), cited by 6
- K113168: Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric (2012), cited by 6

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