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510(k) Data Aggregation

    K Number
    K231910
    Device Name
    DermRays Revive
    Manufacturer
    Wuhan Lotuxs Technology Co., Ltd.
    Date Cleared
    2024-01-30

    (215 days)

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

    Wuhan Lotuxs Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DermRays Revive is intended for hair reduction. Permanent hair reduction is 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. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
    Device Description
    DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water). Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs. The device consists of a power adapter, a power cord and a main unit.
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    K Number
    K232117
    Device Name
    Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
    Manufacturer
    Wuhan Lotuxs Technology Co., Ltd.
    Date Cleared
    2023-11-28

    (134 days)

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

    Wuhan Lotuxs Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
    Device Description
    The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
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    K Number
    K230090
    Device Name
    Diode Laser Hair Removal
    Manufacturer
    Wuhan Lotuxs Technology Co., Ltd.
    Date Cleared
    2023-04-19

    (97 days)

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

    Wuhan Lotuxs Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Har Removal is also intended for permanent reduction in hair regrowth defined as a 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 Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810mm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
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    K Number
    K191068
    Device Name
    Powersculp laser lipolysis system
    Manufacturer
    Wuhan Lotuxs Technology Co., Ltd.
    Date Cleared
    2019-07-17

    (86 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuhan Lotuxs Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.
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