# K143190: Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Yung Sheng Optical Co., Ltd.
- Decided: Jan 16, 2015 after 72 days
- Product code: MVN (Lens, Contact, (Disposable))
- 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: 3 generations back to K960926 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132854: Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear, Yung Sheng Optical Co., Ltd. (2013) Summary page 4.

## Indications for use
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day 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/K143190
Methodology: https://510kreport.com/methodology