# K141348: Visco Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Visco Vision, Inc.
- Decided: Jun 22, 2015 after 396 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: 5 generations back to P810005 (1981). 7 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052560: Biofinity (Comfilcon a) Soft Contact Lens, CooperVision, Inc. (2005) Summary page 5.

## Most influential descendants
- K160344: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 (2016), 8 descendants of its own
- K171447: OxyPure Color Silicone Hydrogel Soft Contact Lenses (2017), 2 descendants of its own
- K193399: Miru 1day UpSide (midafilcon A) (2020), 1 descendant of its own
- K180322: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens (2018), 1 descendant of its own
- K262495: Miru 1day UpSide (midafilcon A) (2026), 0 descendants of its own

## Indications for use
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K141348
Methodology: https://510kreport.com/methodology