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510(k) Data Aggregation

    K Number
    K250425
    Device Name
    Ultraviolet Phototherapy Device
    Manufacturer
    APK Technology Co., Ltd.
    Date Cleared
    2025-04-07

    (52 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultraviolet Phototherapy Device 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
    Ultraviolet Phototherapy Device
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    K Number
    K244022
    Device Name
    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
    Manufacturer
    Boston Aesthetics INC
    Date Cleared
    2025-03-13

    (76 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.
    Device Description
    The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households. The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only. The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.
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    K Number
    K242977
    Device Name
    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
    Manufacturer
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Cleared
    2025-02-06

    (133 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
    Device Description
    Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed countries such as Europe and America.
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    K Number
    K242908
    Device Name
    UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
    Manufacturer
    Shanghai SIGMA High-tech Co., Ltd.
    Date Cleared
    2024-12-19

    (86 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.
    Device Description
    UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and eczema. It is to be used on intact skin only. Patients shall use it at home under the quidance of the doctor. Users can set UV irradiation dose through the controller, and confirm the light emission by pressing the start button. The controller will control the light emitting time of the set dose. The light emission will stop automatically after the UV irradiation dose reaches the set value.
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    K Number
    K233811
    Device Name
    DT Controlled Phototherapy Equipment
    Manufacturer
    Daavlin Distributing Co.
    Date Cleared
    2023-12-13

    (14 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
    Device Description
    The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.
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    K Number
    K223882
    Device Name
    Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
    Manufacturer
    Shenzhen Honpal Optoelectronic Technology Co., Ltd.
    Date Cleared
    2023-03-27

    (90 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
    Device Description
    The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02. The device can be used in hospitals, clinics and households.
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    K Number
    K230382
    Device Name
    3 Series NeoLux
    Manufacturer
    Daavlin Distributing Co.
    Date Cleared
    2023-03-24

    (39 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
    Device Description
    The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length). Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface. The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001. While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.
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    K Number
    K230076
    Device Name
    Enhanced AURORA™ Medical Diode System, and related accessories
    Manufacturer
    Psoria-Shield, Inc.
    Date Cleared
    2023-03-08

    (57 days)

    Product Code
    FTC, GEX
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
    Device Description
    The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area. The device is comprised of four main components: - A base station - A touchscreen where the user can enter system commands - Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece. - A printer accessory that can print out verification of treatment parameters for hard copy records.
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    K Number
    K220840
    Device Name
    1 Series Phototherapy Equipment
    Manufacturer
    Daavlin Distributing Co.
    Date Cleared
    2022-04-22

    (30 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K210004
    Device Name
    i8 Tanning Booth
    Manufacturer
    Ultrasun International B.V.
    Date Cleared
    2021-12-10

    (340 days)

    Product Code
    FTC, CLA, LEJ
    Regulation Number
    878.4630
    Why did this record match?
    Product Code :

    FTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
    Device Description
    Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.
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