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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?
    Product Code :

    NXV

    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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    K Number
    K123169
    Device Name
    ORALID
    Manufacturer
    FORWARD SCIENCE LLC
    Date Cleared
    2013-03-13

    (155 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OralID™ is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
    Device Description
    OrallD™ is a battery operated (CR123A), hand-held, oral illumination and examination light designed for use by dental and medical professionals to be used as an adjunctive tool for fluorescence visualization of oral mucosal tissue. OralID™ accessories include two pair of filtered eyewear for both the clinician and patient.
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    K Number
    K121282
    Device Name
    MICROLUX/DL MICROLUX/BLU BIO/SCREEN
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2012-07-24

    (85 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
    Device Description
    The ORABLU Oral Lesion Marking System is a three component swab system.
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    K Number
    K102083
    Device Name
    VELSCOPE VX
    Manufacturer
    LED DENTAL INC.
    Date Cleared
    2010-11-18

    (115 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. VELscope Vx is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    The VELscope Vx system is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination. The main components of VELscope are the Handpiece, incorporating light source, viewing optics and rechargeable battery. Charging Cradle and external power supply. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal green fluorescence pattern of surrounding health tissue.
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    K Number
    K101140
    Device Name
    DENTLIGHT ORAL EXAM LIGHT KIT
    Manufacturer
    DENTLIGHT INC.
    Date Cleared
    2010-07-15

    (84 days)

    Product Code
    NXV, EAQ
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
    Device Description
    Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for illumination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue. Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.
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    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?
    Product Code :

    NXV

    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
    K082668
    Device Name
    BIO-SCREEN
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2009-01-23

    (133 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders
    Device Description
    This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tissue and improve visualization
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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?
    Product Code :

    NXV

    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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    K Number
    K080043
    Device Name
    VIZILITE EYEWEAR
    Manufacturer
    ZILA, INC.
    Date Cleared
    2008-04-04

    (87 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam. INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
    Device Description
    The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
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    K Number
    K073483
    Device Name
    SAPPHIRE O/E ORAL EXAMINATION SYSTEM
    Manufacturer
    DEN-MAT HOLDINGS, LLC
    Date Cleared
    2008-04-03

    (114 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Product Code :

    NXV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    Not Found
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