# K181656: ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

- Pathway: 510(k) (Traditional)
- Applicant: Eyemed Technologies S.R.L.
- Decided: Mar 5, 2019 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: 3 generations back to K051477 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161098: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color), Joowon Innovation Co., Ltd. (2016) Summary page 4.

## Indications for use
The ADORE (polymacon) Spherical Soft Contact Lenses are 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 persons who exhibit refractive astigmatism of 0.75 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. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Source page: https://510kreport.com/device/K181656
Methodology: https://510kreport.com/methodology