# K220045: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medivision Co., Ltd.
- Decided: Aug 5, 2022 after 212 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: 3 generations back to K960926 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 5.
- K161098: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color), Joowon Innovation Co., Ltd. (2016) Summary page 5.

## Indications for use
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.

Source page: https://510kreport.com/device/K220045
Methodology: https://510kreport.com/methodology