# K103132: Freshkonalluring Eyes, Freshkon Colors Fusion, Freshkoncolors Fusion Sparklers, Freshkon Mosaic, Freshkon Glitzi

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Private Limited
- Decided: Sep 8, 2011 after 318 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K103132
Methodology: https://510kreport.com/methodology