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510(k) Data Aggregation

    K Number
    K240132
    Device Name
    EmoLED (v. 2-USA)
    Manufacturer
    Date Cleared
    2024-03-12

    (55 days)

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

    Emoled, Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
    Device Description
    Emol.ED is a portable, reusable medical device powered by rechargeable lithium-ion batteries that illuminate six (6) LED light sources which emit non-coherent blue light between 415 ± 5 nanometers (nm). The EmoLED device emits a uniform and constant optical power intensity of 120 mW/cm2 over an area of approx. 50.3 cm in diameter) at a distance of 4 +/- 1 cm. The EmoLED device consists of: a polycarbonate body containing a software-controlled processor that controls the emission of light; . a touch screen (display), placed in the front part of the device that allows the operator to control the device; a multi-function (on/off) button, placed in the posterior part of the body of the device; a power jack and a micro-USB plug, placed on the left side of the body of the device; an optic part containing the LED light source, the LED's control board, an optical lens (optic head) and a distance sensor connected to the body which can be rotated by the operator up to 180° to project the light beam on the desired skin surface; accessories, which include a visual comfort screen and 24V power supply (with an integrated connection cable).
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