# K011893: Cosmetica (Polymacon) Soft (Hydrophilic) Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Contact Color Srl
- Decided: Dec 6, 2001 after 171 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 P810005 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001089: Polymacon, CooperVision, Inc. (2000) Summary page 1.
- P810005: Weicon (R) (Tefilicon) Hydrophilic Contact Lens, Ciba Vision Care (1981) Summary page 1.

## Indications for use
The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using chemical disinfection systems.

Source page: https://510kreport.com/device/K011893
Methodology: https://510kreport.com/methodology