Search Filters

Search Results

Found 33 results

510(k) Data Aggregation

    K Number
    K251031
    Device Name
    Fiber Laser Treatment Systems (HS-232,HS-233)
    Manufacturer
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Cleared
    2025-07-02

    (90 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250402
    Device Name
    AVAVA™ Skin Treatment System
    Manufacturer
    Avava Inc
    Date Cleared
    2025-04-14

    (61 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
    Device Description
    The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA. The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface. The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
    Ask a Question
    K Number
    K233550
    Device Name
    MOSAIC 3D (Surgical Laser)
    Manufacturer
    Lutronic Aesthetic
    Date Cleared
    2024-01-02

    (60 days)

    Product Code
    ONG, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.
    Device Description
    The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece. When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect. The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.
    Ask a Question
    K Number
    K223871
    Device Name
    Miria Skin Treatment System
    Manufacturer
    Avava, Inc.
    Date Cleared
    2023-06-22

    (181 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
    Device Description
    The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA. The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface. The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
    Ask a Question
    K Number
    K221268
    Device Name
    SR-1 Skin Treatment System
    Manufacturer
    AVAVA, Inc
    Date Cleared
    2022-11-21

    (203 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
    Device Description
    The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA. The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface. The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
    Ask a Question
    K Number
    K221770
    Device Name
    Fiber Laser Treatment System
    Manufacturer
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Cleared
    2022-10-13

    (114 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
    Device Description
    The Fiber laser Treatment system (HS-230) is the desktop type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system), fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
    Ask a Question
    K Number
    K213332
    Device Name
    Multifrax Laser System
    Manufacturer
    Paradigm Medical Corporation
    Date Cleared
    2022-06-03

    (240 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
    Device Description
    The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin. Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy. - Multifrax is a non-ablative and non-invasive fractional laser device. - Multifrax is a light portable laser combining a small laser unit and 2 long lasting rechargeable batteries equipped with a belt clip. - Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.
    Ask a Question
    K Number
    K202884
    Device Name
    SR-1 Skin Treatment System
    Manufacturer
    AVAVA, Inc.
    Date Cleared
    2021-04-13

    (197 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. The SR-1 Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The SR-1 Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
    Device Description
    The SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the optics, scanner, laser aperture, and contact cooling interface. The SR-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
    Ask a Question
    K Number
    K192350
    Device Name
    Medical Non-Ablative Fractional Laser Systems
    Manufacturer
    Wingderm Electro-Optics Ltd.
    Date Cleared
    2020-04-30

    (245 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
    Device Description
    The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece. The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components. The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc. The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.
    Ask a Question
    K Number
    K182498
    Device Name
    Advanced Skin Renewing Device
    Manufacturer
    Jiangsu Unimed Laser Technology Co., Ltd.
    Date Cleared
    2018-11-30

    (79 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    ONG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced Laser Device is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.
    Device Description
    Advanced Laser Device
    Ask a Question

    Page 1 of 4