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510(k) Data Aggregation

    K Number
    K240222
    Device Name
    Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
    Manufacturer
    Aesthetic Technology Ltd
    Date Cleared
    2024-06-04

    (130 days)

    Product Code
    GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesthetic Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use include: · The blue light (415nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. · The red light (633nm wavelength) indicated for treatment of superficial, benign, vascular and pigmented lesions. • The near-infrared light (830nm wavelength) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR Class II) which emits specific wavelengths of low level, narrow band light for the treatment of certain aesthetic, dermatological and medical indications. The wavelengths used in the Tri-Wave MD MK II & Compact MD systems are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux professional use family consists of the Tri-Wave MD MKI; a floor standing unit with 4 pod treatment head, Compact MD; desk mounted unit with a 3 pod treatment head. The system enables treatment of the body via an articulated 4 or 3 panel LED head. The panels can be easily adjusted for focused intensity treatments and application to larger body areas. The system consists of a main body that contains the power supply (100-240Vac, 50/60Hz), power switch, touch screen control panel and a 4 or 3 panel adjustable treatment head that contains Light Emitting Diodes (LEDs). The power supply is designed to power the internal electronics for the system and the Light Emitting Diodes. The power supply is connected to a suitable mains outlet. The device is switch located below the screen in the base unit. The Tri-Wave MD MK II & Compact MD system is operated by a full colour capacitive touch screen which features pre-set and post treatment protocols that can be customised with three power settings. Bespoke protocols can be programmed based on delivered energy or time. The device cannot be networked or connect to the internet, software updates can be performed via a USB flash drive (thumb drive) if required. The light is generated by Light Emitting Diodes (LED's) which a treatment head. The treatment head is connected to the main body by articulating arm mechanism. The arm allows the operator to correctly position the LED head ment area. Protective eye wear is supplied with each Dermalux unit for patient and operator comfort. The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
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    K Number
    K212275
    Device Name
    Dermalux Flex MD
    Manufacturer
    Aesthetic Technology Ltd.
    Date Cleared
    2021-11-18

    (121 days)

    Product Code
    OHS, ILY, OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesthetic Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the treatment of periorbital and full face wrinkles.
    Device Description
    The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected through selecting various wavelengths. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.
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    K Number
    K202028
    Device Name
    dermalux Flex MD
    Manufacturer
    Aesthetic Technology Ltd
    Date Cleared
    2020-12-16

    (147 days)

    Product Code
    ILY, GEX, OHS, OLP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesthetic Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.
    Device Description
    The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected, through selecting various wavelength combinations. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.
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    K Number
    K200659
    Device Name
    Dermalux Tri-Wave MD
    Manufacturer
    Aesthetic Technology Ltd.
    Date Cleared
    2020-05-09

    (58 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesthetic Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near-infrared light (830nm wavelength) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Dermalux® Tri-Wave MD is a floor standing Class II medical device which emits specific wavelengths of low level, narrow band light for the treatment of dermatological conditions. The wavelengths used in the Tri-Wave MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. The device consists of a main body that contains the power supply, power switch, touch screen control panel, and a 4 panel adjustable treatment head that contains Light Emitting Diodes enabling treatment of the face and the body. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.
    Ask a Question

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