# K042435: Cooper Prosthetic

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Oct 26, 2004 after 48 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 K950283 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984259: Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Cl-Tinters (1999) Summary page 3.
- K010126: Prosthetic, Gelflex Alpha, (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Cl-Tinters (2001) Summary page 3.

## Indications for use
The Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is 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 management of conditions such as 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 that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Source page: https://510kreport.com/device/K042435
Methodology: https://510kreport.com/methodology