# K182734: Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

- Pathway: 510(k) (Traditional)
- Applicant: Unicon Optical Co., Ltd.
- Decided: May 16, 2019 after 230 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: 7 generations back to K962804 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172692: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Tangible Science, LLC (2017) Summary page 5.

## Indications for use
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

Source page: https://510kreport.com/device/K182734
Methodology: https://510kreport.com/methodology