# K050743: Aquaflex 2 (Tefilcon) Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Unilens Corp., USA
- Decided: Apr 13, 2005 after 23 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) BayVue (polymacon) Soft (hydrophilic) Contact Lens: named in the summary without a submission number

## Most influential descendants
- K110452: Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2, (2011), 0 descendants of its own

## Indications for use
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Source page: https://510kreport.com/device/K050743
Methodology: https://510kreport.com/methodology