# K052606: Marietta Contact Lens (Polymacon), Tinted Daily Wear Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Marietta Vision
- Decided: Dec 15, 2005 after 84 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 K942302 (1994). 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)
- K942302: Addvantage 38 Aspheric Soft Contact Lens, Preferred Optics, Inc. (1994) Summary page 2.
- K002647: Marietta Contact Lens Service, Color Enhanced Tinted Soft Contact Lens, Marietta Contact Lens Service (2000) Summary page 2.

## Indications for use
The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. 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 may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K052606
Methodology: https://510kreport.com/methodology