# K962000: Flexlens (Methafilcon a)

- Pathway: 510(k) (Traditional)
- Applicant: Flexlens, Inc.
- Decided: Oct 1, 1996 after 132 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
Longest line of descent: 1 generation back to K950294 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950294: Flexlens 55 Soft (Hydrophilic) Contact Lens, Flexlens, Inc. (1996) Summary page 2.

## Indications for use
The FLEXTENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Lens is indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

Source page: https://510kreport.com/device/K962000
Methodology: https://510kreport.com/methodology