# K954603: Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Jan 4, 1996 after 92 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K013377: Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2001), 4 descendants of its own
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (2018), 2 descendants of its own
- K242916: Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (2025), 0 descendants of its own
- K202129: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo (2021), 0 descendants of its own
- K152657: SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K954603
Methodology: https://510kreport.com/methodology