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510(k) Data Aggregation

    K Number
    K151630
    Device Name
    G.o.c.c.l.e.s.
    Manufacturer
    PIERREL PHARMA S.R.L.
    Date Cleared
    2015-09-15

    (90 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIERREL PHARMA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    G.o.c.c.l.e.s. is intended to be used by a qualified health-care providers to enhance the identification and visualization of the oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. G.o.c.l.e.s. eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of blue light during oral exam.
    Device Description
    The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. light proprietary light source (emission range 440-490nm), in order to allow the examination of autofluorescence of the oral cavity and consequently detect oral abnormalities such as dysplastic or anaplastic lesions (carcinomas of the oral mucosa). The device looks like a pair of glasses, characterized by reduced dimensions, good wearability, easy portability and proper filtering performances in order to allow to filter the fluorescence emission, resulting from the fluorophore of interest (Flavin Adenine Dinucleotide (FAD)), which in its oxidized form responds to a light of 450nm (blue-violet) emitting a fluorescence wavelength of around 515nm (green).
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