# K984259: Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)

- Pathway: 510(k) (Traditional)
- Applicant: Cl-Tinters
- Decided: Jan 21, 1999 after 52 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: 2 generations back to K950283 (1995). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971049: Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Aspect Vision Care, Ltd. (1997) Summary page 1.

## Most influential descendants
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants of its own
- K042435: Cooper Prosthetic (2004), 0 descendants of its own
- K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear (2004), 0 descendants of its own
- K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens (2002), 0 descendants of its own

## Indications for use
Prosthetic (polymacon) Hydrophilic Contact Lens (clear and tinted) 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. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K984259
Methodology: https://510kreport.com/methodology