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510(k) Data Aggregation

    K Number
    K243372
    Device Name
    BiliWrap
    Manufacturer
    Gerium Medical, Ltd.
    Date Cleared
    2025-05-29

    (211 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliWrap Phototherapy System is intended for use to treat infants who have been diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The Phototherapy system can be used in a hospital or at home. The device is intended to be used in infants up to the age of 3 months, weighing less than 10 kg.
    Device Description
    The BiliWrap Phototherapy System is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover and AC/DC power supply. The pad is designed to cover the torso and legs and provide phototherapy treatment on large surface area of the baby. The BiliWrap Phototherapy System emits light in the spectrum of 450 to 475 nm, a spectrum known as effective to reduce bilirubin concertation in the body of infants. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
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    K Number
    K210289
    Device Name
    Infant Phototherapy Equipment
    Manufacturer
    Bistos Co., Ltd.
    Date Cleared
    2021-05-28

    (115 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
    Device Description
    Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby. Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used). Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
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    K Number
    K200031
    Device Name
    Neonatal Phototherapy System
    Manufacturer
    Avalon Biomedical (Shenzhen) Limited
    Date Cleared
    2020-10-05

    (272 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.
    Device Description
    The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia. The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy. The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up. The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard. Average irradiance for: Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%); Single Fiber Optic Panel: 60 uW/cm2/nm (±25%). The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation. The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.
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    K Number
    K190899
    Device Name
    bili-hut
    Manufacturer
    Little Sparrows Technologies, Inc.
    Date Cleared
    2019-09-05

    (150 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.
    Device Description
    The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice. The bili-hut™ consists of the assembled hut (shell with light source, base mattress, base), nest components (nest, nest liner, nest mattress, nest mattress cover), and power supply. It has an optional accessory, the perch, which is a bassinet stand insert. Features include a timer for total LED use and an Environment High Temperature Warning with automatic shutoff. The principle of operation is phototherapy using blue light to break down bilirubin. The device is powered by a 12V medical grade power supply and uses an LED light array. The materials include fabric-based, plastic, metal, and electronic components.
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    K Number
    K182178
    Device Name
    neoBLUE blanket LED Phototherapy System
    Manufacturer
    Natus Medical Incorporated
    Date Cleared
    2018-12-13

    (122 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.
    Device Description
    The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia. The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.
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    K Number
    K172656
    Device Name
    BiliLux
    Manufacturer
    Draeger Medical Systems, Inc.
    Date Cleared
    2018-05-01

    (238 days)

    Product Code
    LBI, CLA
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
    Device Description
    The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb). The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur. The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light.
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    K Number
    K170585
    Device Name
    Skylife
    Manufacturer
    NeoLight, LLC
    Date Cleared
    2017-10-27

    (241 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.
    Device Description
    Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm. Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital. Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply.
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    K Number
    K163526
    Device Name
    Bilicocoon™ Phototherapy System
    Manufacturer
    NEOMEDLIGHT
    Date Cleared
    2017-10-06

    (294 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
    Device Description
    The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed. The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin. The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
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    K Number
    K160745
    Device Name
    neoBLUE compact LED Phototherapy System
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Date Cleared
    2016-12-12

    (269 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
    Device Description
    The neoBLUE compact LED Phototherapy System utilizes a portable phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE compact LED Phototherapy System light consists of a lightweight plastic light enclosure which can be used independently by placing directly on top of an incubator, or with the arm, or with the arm and roll stand together. The arm can be attached to the pole mount accessory on most incubators and radiant warmers. The arm, when attached to the roll stand, can be used for infants in a bassinet, incubator, open bed, or radiant warmer. The neoBLUE compact LED Phototherapy System light is equipped with a treatment timer to track the total number of treatment hours per patient, a device timer to track the total number of operating hours for the blue LEDs, and an exam light.
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    K Number
    K160238
    Device Name
    Airborne Phototherapy Light
    Manufacturer
    INTERNATIONAL BIOMEDICAL
    Date Cleared
    2016-06-14

    (134 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Product Code :

    LBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
    Device Description
    The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood
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