# K213983: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Yung Sheng Optical Co., Ltd.
- Decided: Sep 2, 2022 after 256 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: 6 generations back to K003136 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens, CooperVision, Inc. (2006) Summary page 4.
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A), Supervision Optimax Sdn Bhd (2017) Summary page 4.

## Indications for use
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Source page: https://510kreport.com/device/K213983
Methodology: https://510kreport.com/methodology