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Freshkonalluring Eyes, Freshkon Colors Fusion, Freshkoncolors Fusion Sparklers, Freshkon Mosaic, Freshkon Glitzi

by Oculus Private Limited

510(k) K103132

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 · Traditional NumberK103132 Date8 Sep 2011ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

The device is a soft contact lens for daily wear, as defined by its device type and nomenclature authority. It is classified as an ophthalmic device under regulation number 886.5925.

The device received FDA 510(k) clearance (K103132) on September 8, 2011, and is substantially equivalent to a legally marketed predicate. It is manufactured by Oculus Private Limited and distributed in the United States.

Other devices from Oculus Private Limited

Questions

AI-generated answers, 23 Sep 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 FRESHKONALLURING EYES used for?

    FRESHKONALLURING EYES is a soft contact lens designed for daily wear, intended to correct vision by being placed directly on the eye. It is classified as an ophthalmic device under regulation number 886.5925 and is used for refractive error correction in patients requiring daily disposable lens wear.

  • How is FRESHKONALLURING EYES supplied and is it sterile?

    FRESHKONALLURING EYES is supplied as a sterile soft contact lens in individual sealed packaging, ensuring sterility until opened. The device is intended for single-use daily wear and must be discarded after each wearing period to maintain safety and prevent contamination.

  • What regulatory clearance does FRESHKONALLURING EYES have?

    FRESHKONALLURING EYES received FDA 510(k) clearance under submission number K103132 on September 8, 2011, and was determined to be substantially equivalent to a legally marketed predicate device. This clearance permits its commercial distribution in the United States for daily wear soft contact lens use.