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510(k) Data Aggregation

    K Number
    K251308

    Validate with FDA (Live)

    Device Name
    SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
    Manufacturer
    Thera B Medical Products
    Date Cleared
    2026-01-15

    (262 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K210289
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SnugLit(TM) Wearable Phototherapy System is intended for use in the treatment of infant hyperbilirubinemia, commonly known as neonatal jaundice. The device can be used in a hospital or at home, by a licensed medical practitioner or by a caregiver under the supervision of a licensed medical practitioner.

    The device has been designed for use with infants of weights between 1.5 – 5.5 kg (approximately 3.5 -12 lbs) and lengths between 40.5 - 57.5 cm (approximately 16 - 23 inches).

    Device Description

    The SnugLit system is a phototherapy device that provides therapeutic blue light to infants using a Light Mat enclosed within a Disposable Swaddle. This system enables infants to receive phototherapy in a bassinet or while being held. The SnugLit is designed to deliver wrap-around phototherapy to infants while being swaddled.

    The SnugLit is composed of a Light Mat, Controller, Disposable Swaddle, and Power Adapter.

    AI/ML Overview

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