# K953807: Daily Wear Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Stephen A. Dunn, Inc.
- Decided: Feb 14, 1996 after 190 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980818: Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense) (1998), 6 descendants of its own
- K013220: HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2001), 4 descendants of its own
- K020608: HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2002), 2 descendants of its own
- K221517: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (2022), 1 descendant of its own
- K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K953807
Methodology: https://510kreport.com/methodology