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Metro Soft

by Metro Optics of Austin, Inc.

510(k) K100244

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 NumberK100244 Date28 Oct 2010ClearedStatusActive

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  • Withdrawn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 Metro Soft is a daily-wear soft contact lens designed for ophthalmic use. Classified as a lens for correcting vision, it is intended for patients requiring custom contact lens solutions, particularly those with challenging fits. These lenses are engineered to provide clear, comfortable vision for extended daily use, adhering to regulatory standards for soft contact lenses.

Metro Soft lenses are supplied as single-use, non-reusable devices intended for daily wear only. They are manufactured under FDA 510(k) clearance (K100244) and fall under Class II medical device regulations (21 CFR 886.5925). The lenses are sterile upon packaging and must be stored according to manufacturer guidelines to preserve sterility and functionality. Multiple FEI numbers denote various sizes and prescriptions available to meet diverse patient requirements.

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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 Metro Soft lens designed for?

    The Metro Soft is a daily-wear soft contact lens specifically engineered to correct vision for patients who require custom contact lens solutions, particularly those with challenging fits. Its design prioritizes clear, comfortable vision for extended daily use, making it suitable for individuals who need tailored ophthalmic correction.

  • Are Metro Soft lenses single-use or reusable?

    Metro Soft lenses are intended for single-use only and are not designed for reuse. Each lens is packaged sterile and must be discarded after one day of use to maintain safety and effectiveness, adhering to standard practices for daily-wear contact lenses.

  • How are the lenses supplied, and what does sterility mean in this context?

    The Metro Soft lenses are supplied individually in sterile packaging, ensuring they are free from contamination upon opening. Sterility in this context means the lenses meet regulatory standards for cleanliness and safety before use, allowing for immediate application without additional sterilization steps.

  • What sizes or prescriptions are available for Metro Soft lenses?

    Metro Soft lenses come in a wide range of sizes and prescriptions, as indicated by multiple FEI (Final Establishment Identification) numbers. These variations allow for customization to meet diverse patient needs, ensuring a proper fit and optimal vision correction for each individual.

  • How should Metro Soft lenses be stored to preserve their functionality?

    To maintain sterility and functionality, Metro Soft lenses must be stored according to the manufacturer’s guidelines. This typically involves keeping them in their original, unopened packaging in a cool, dry place, away from direct sunlight or extreme temperatures, until ready for use.