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Confees+ Contact Lens Holder

by Magnivision, Inc.

510(k) K897084

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 NumberK897084 Date28 Feb 1990ClearedStatusActive

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  • Withdrawn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)

Full name
Confees(R)+ Contact Lens Holder
510(k) Number
FDA Product Code
LRX
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Confees+ Contact Lens Holder is a Case, Contact Lens designed to store and protect soft (hydrophilic) contact lenses. It provides a dedicated, enclosed space to maintain lens hygiene and integrity between use.

This device is intended for single-use or reusable storage of contact lenses, supplied sterile or non-sterile as specified by the manufacturer. It is classified as a Class II medical device under FDA regulation 886.5928 and holds an FDA 510(k) clearance (K897084) with a product code of LRX. Storage conditions and reuse instructions are detailed in the manufacturer’s instructions.

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Questions

AI-generated answers, 19 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 types of contact lenses is the Confees+ Contact Lens Holder designed to store and protect?

    The Confees+ Contact Lens Holder is specifically designed for storing and protecting soft (hydrophilic) contact lenses. It provides an enclosed space to maintain lens hygiene and integrity between uses, ensuring compatibility with this lens type.

  • Is the Confees+ Contact Lens Holder intended for single-use or reusable storage, and how should I determine which version I need?

    The Confees+ Contact Lens Holder can be used for both single-use and reusable storage, depending on the version purchased. The manufacturer specifies whether each unit is sterile or non-sterile, so check the packaging or instructions to confirm which version aligns with your needs—sterile for one-time use or non-sterile for reuse.

  • How should I store the Confees+ Contact Lens Holder to maintain its effectiveness?

    Storage conditions are outlined in the manufacturer’s instructions, but generally, the holder should be kept in a clean, dry environment to prevent contamination. Avoid exposure to extreme temperatures or moisture, as this could compromise its integrity or the lenses it stores. Always follow the provided guidelines for optimal preservation.

  • Are there different sizes or models of the Confees+ Contact Lens Holder, and if so, how do I identify which one is right for me?

    The Confees+ Contact Lens Holder is listed under multiple registration numbers, but the specific sizes or models aren’t detailed in the provided data. However, since it’s designed for soft contact lenses, compatibility depends on the lens brand and type rather than the holder’s size. Verify the manufacturer’s instructions or consult a healthcare provider to ensure the correct fit for your lenses.