# K210609: AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Vp Optics
- Decided: Apr 27, 2021 after 57 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 K051477 (2006). 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)
- K142275: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens, Neo Vision Co., Ltd. (2014) Summary page 5.

## Indications for use
The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia and hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 3.00 diopters or less. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe the lens for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K210609
Methodology: https://510kreport.com/methodology