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510(k) Data Aggregation

    K Number
    K090135
    Device Name
    TRIMIRA IDENTAFI 3000
    Manufacturer
    REMICALM, LLC
    Date Cleared
    2009-02-17

    (27 days)

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

    REMICALM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescene and reflectance, and vasculature. Identaff™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision. Identafi™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identafi™ 3000 eyewear bacbeen designed to allow transmission of 430-580 nm light.
    Device Description
    The TRIMIRA™ IDENTAFI 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories outli oldi glasses and disposable mirrors. The Identaff™ 3000, with multispectral identifi™ technology (patents pending), uses "AA" batteries to operate high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white ight, and specialized or enhanced visual examinations of tissue using violet and amber lights. The Identafi™ 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues fluorescing blue (when using rose colored filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the withio suspicious assus app and makes visualization of the vasculature possible. The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation.
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    K Number
    K082603
    Device Name
    TRIMIRA OCS 3000
    Manufacturer
    REMICALM, LLC
    Date Cleared
    2008-12-12

    (95 days)

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

    REMICALM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OCS 3000® is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. OCS 3000® allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature. OCS 3000® is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision. OCS 3000 eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000 eyewear has been designed to allow transmission of 430-580 nm light.
    Device Description
    The TRIMIRA™ OCS 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories include safety glasses and disposable mirrors. OCS 3000® eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000® eyewear has been designed to allow transmission of 430-580 nm light. The OCS 3000 with multispectral identifi™ technology (Patent No. 7,365,844 and patents pending) uses "AA" batteries to operated high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white light, and specialized or enhanced visual examinations of tissue using violet and amber lights. The OCS 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues in fluorescing green (when using filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the tissue's natural reflectance and makes visualization of the vasculature possible. The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation. The loss of natural tissue fluorescence and reflectance can identify subclinical high-risk fields with cancerous and precancerous changes Clinical Cancer Research Vol. 12, 6716-6722. November 15, 2006.
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