# P830037: Durasoft (R) 3 for Ext Wear

- Pathway: PMA
- Applicant: Alcon Laboratories, Inc.
- Decided: Apr 24, 1984 after 292 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K050213: Freshlook One-Day Color Contact Lens (2005), 21 descendants of its own
- K083216: Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses (2009), 10 descendants of its own
- K123484: Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact Lens (2013), 8 descendants of its own
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (2016), 7 descendants of its own
- K153643: Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (2016), 7 descendants of its own

## Recalls of this device
- Jan 17, 2003 · Not classified · Z-0787-03: FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
- Dec 16, 2002 · Not classified · Z-0405-03: Mislabeling

Source page: https://510kreport.com/device/P830037
Methodology: https://510kreport.com/methodology