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Marietta Contact Lens (Polymacon), Tinted Daily Wear Contact Lens

by Marietta Vision

510(k) K052606

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK052606 Date15 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Marietta Contact Lens (Polymacon) is a soft contact lens for daily wear, made of polymacon material. It is designed for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes affected by myopia or hyperopia, and to enhance or alter the apparent eye color.

This device is supplied as a tinted lens and is classified as Class II under special controls. It received FDA 510(k) clearance with number K052606 on December 15, 2005, and is manufactured by Marietta Vision in Grand Junction, Colorado. The lens is indicated for daily wear use in persons with non-diseased eyes.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Marietta Contact Lens used for?

    The Marietta Contact Lens (Polymacon) is a soft contact lens designed for daily wear to correct visual acuity in aphakic and non-aphakic persons with non-diseased eyes affected by myopia or hyperopia, and to enhance or alter the apparent eye color.

  • Is the Marietta Contact Lens sterile and single-use?

    The device is supplied as a tinted lens and is classified as Class II under special controls. However, the description does not specify whether it is sterile or single-use, so this information would need to be confirmed with the manufacturer.

  • What are the regulatory approvals for the Marietta Contact Lens?

    The Marietta Contact Lens received FDA 510(k) clearance with number K052606 on December 15, 2005, and is classified as Class II under special controls. It is manufactured by Marietta Vision in Grand Junction, Colorado.

  • What material is the Marietta Contact Lens made of?

    The Marietta Contact Lens is made of polymacon material, which is a soft contact lens material designed for daily wear comfort and visual correction.