# K950294: Flexlens 55 Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Flexlens, Inc.
- Decided: Apr 11, 1996 after 442 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K030593: Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B), (Acofilcon a), (Acofilcon B) Soft Contac (2003), 0 descendants of its own
- K023077: Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear (Lathe-Cut) (2002), 0 descendants of its own
- K962000: Flexlens (Methafilcon a) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K950294
Methodology: https://510kreport.com/methodology