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510(k) Data Aggregation

    K Number
    K243362
    Device Name
    SmoothSkin Pure Switch (SSC1)
    Manufacturer
    CyDen Limited
    Date Cleared
    2024-11-27

    (29 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    The SSC1 device is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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    K Number
    K240587
    Device Name
    SmoothSkin Pure Unplugged (SSB3)
    Manufacturer
    CyDen Limited
    Date Cleared
    2024-03-29

    (28 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    The SmoothSkin Pure Unplugged is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is battery powered and charged by mains. The handset with removal battery pack, Handset Dock station, and AC Adapter. AC mains is fed to the AC Adapter and converted to DC to charge the battery pack via the docking station contact pins, the device cannot be used when charging. The battery pack is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the absorbed light energy is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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    K Number
    K233782
    Device Name
    SmoothSkin Pure Adapt (SSG3)
    Manufacturer
    CyDen Limited
    Date Cleared
    2023-12-20

    (23 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    The SmoothSkin Pure Adapt is an over the counter IPL (Intense Pulsed Light) Hair Removal device for home use. The device is mains powered and consists of the handset, hardwired base unit and AC power cord. AC mains is fed into the AC to DC converter that is used to charge the electrical storage capacitor, the stored energy is used to produce an optical output from the flash lamp. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair sharty is converted to heat energy (below the surface of the skin), which reduces the hairs growing back.
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    K Number
    K230911
    Device Name
    Braun Skin i.expert
    Manufacturer
    CyDen Limited
    Date Cleared
    2023-04-27

    (27 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K213692
    Device Name
    SmoothSkin Pure Mini
    Manufacturer
    CyDen Limited
    Date Cleared
    2022-01-26

    (64 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K211994
    Device Name
    Braun Silk.expert Mini
    Manufacturer
    CyDen Limited
    Date Cleared
    2021-07-28

    (30 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRAUN Silk.expert Mini Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K200184
    Device Name
    SmoothSkin Pure
    Manufacturer
    CyDen Limited
    Date Cleared
    2020-02-21

    (28 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K192010
    Device Name
    SmoothSkin BARE+
    Manufacturer
    CyDen Limited
    Date Cleared
    2019-09-24

    (57 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmoothSkin BARE+ Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin BARE+ is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K190354
    Device Name
    BRAUN Silk.expert Pro 5
    Manufacturer
    CyDen Limited
    Date Cleared
    2019-03-18

    (31 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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    K Number
    K190366
    Device Name
    BRAUN Silk Expert Pro 3
    Manufacturer
    CyDen Limited
    Date Cleared
    2019-03-18

    (31 days)

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

    CyDen Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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