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510(k) Data Aggregation

    K Number
    K212073
    Device Name
    Alma Diode Tabletop Laser
    Manufacturer
    Alma Lasers, Ltd.
    Date Cleared
    2022-07-14

    (377 days)

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

    Alma Lasers, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules: The indications for use for the 810 nm Alma Diode Tabletop Laser include: -The Alma 810 rm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins. The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 mm diode tabletop laser assisted lipolysis. The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.
    Device Description
    The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.
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    K Number
    K203441
    Device Name
    The Alma Hybrid Laser System
    Manufacturer
    Alma Lasers, Ltd.
    Date Cleared
    2021-07-02

    (221 days)

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

    Alma Lasers, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: · Laser skin resurfacing (ablation and/or vaporization) of soft tissue. The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: · Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
    Device Description
    The Alma Hybrid Laser System consists of: - Laser system console (containing the optical bench assembly and laser, the ● microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) - LCD control panel with touch-screen technology: the LCD display provides information . on the status and settings of the The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system. - Two wavelengths – CO2 and 1570 nm - . Articulated arm - Footswitch - Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator) ●
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