# K961943: Flexlens

- Pathway: 510(k) (Traditional)
- Applicant: Flexlens, Inc.
- Decided: Oct 1, 1996 after 134 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FLEXTENS Custom Sphere: named in the summary without a submission number

## Most influential descendants
- K080512: Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint (2008), 9 descendants of its own
- K100244: Metro Soft (2010), 8 descendants of its own
- K123120: Lensx Laser System (2012), 5 descendants of its own
- K161288: LenSX Laser System (2016), 4 descendants of its own
- K163551: LenSx Laser System (2017), 3 descendants of its own

## Indications for use
The FLEXTENS (hefilcon 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/K961943
Methodology: https://510kreport.com/methodology