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510(k) Data Aggregation

    K Number
    K253871

    Validate with FDA (Live)

    Device Name
    Klär Lite (RCW-KL1000)
    Manufacturer
    Radcliffe Watts, LLC
    Date Cleared
    2026-03-04

    (90 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K170489
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Klär Lite is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

    Device Description

    The Klär Lite is a narrowband UVB light emitting phototherapy medical device intended for treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

    AI/ML Overview

    N/A

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