# P960039: Soft-55 EW Aphakic, Vifilcon a (Soft Contacts for Extended Wear)

- Pathway: PMA
- Applicant: Unilens Corporation, USA
- Decided: Apr 17, 1997 after 169 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/P960039
Methodology: https://510kreport.com/methodology