# K200618: HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Visco Vision, Inc.
- Decided: Dec 7, 2020 after 273 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: 2 generations back to K992692 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040303: 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens, Hydrogel Vision Corporation (2005) Summary page 4.
- K992692: Extreme H20 (Hioxifilicon a) Soft Contact Lens, Benz Research and Development Corp. (1999) Summary page 4.

## Indications for use
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Source page: https://510kreport.com/device/K200618
Methodology: https://510kreport.com/methodology