# K123431: Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II (Polymacon) Soft (Hydrophilic) Contact Lens, D

- Pathway: 510(k) (Traditional)
- Applicant: Dreamcon Co., Ltd.
- Decided: Jun 17, 2013 after 222 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: 1 generation back to K051477 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051477: Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic), Mi Gwang Contact Lens Co., Ltd. (2006) Summary page 1.

## Indications for use
The Dream Color |, Il, and Il (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eyes. Eyecare practitioners may prescribe 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

Source page: https://510kreport.com/device/K123431
Methodology: https://510kreport.com/methodology