# LPM: Lenses, Soft Contact, Extended Wear

- Device class: 3; regulation: 21 CFR 886.5925; FDA's rule: PMA required
- FDA decisions: 37
- Recalls: 16 (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: 79
- 2018: 59
- 2019: 55
- 2020: 45
- 2021: 28
- 2022: 40
- 2023: 15
- 2024: 31
- 2025: 31
- 2026: 23

## Most-cited predicates
- P890023: H55 Hydrophilic Contact Lens (1989), cited by 6
- P830037: Durasoft (R) 3 for Ext Wear (1984), cited by 5
- P810005: Weicon (R) (Tefilicon) Hydrophilic Contact Lens (1981), cited by 3
- P780007: Hydron Hydrophilic Contact Lens (1979), cited by 2
- P820021: Softcon (Vifilcon a) Soft Contact Ext Wear Lens (1983), cited by 2
- P830047: X-70 Soft Contact Lens (1985), cited by 1
- P980006: Pure Vision Visibility Tinted Contact Lens for Extended Wear (1999), cited by 1
- P010019: Focus Night and Day (Lotrafilcon a) Soft Contact Lenses (2001), cited by 1
- P940013: Precision (TM) UV (Vasurfilcon) (1994), cited by 1
- P820086: Cibatint (TM) Tinting Process (1984), cited by 1

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