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510(k) Data Aggregation

    K Number
    K253965

    Validate with FDA (Live)

    Date Cleared
    2026-03-19

    (98 days)

    Product Code
    Regulation Number
    890.5500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    (1) The CureLight Medical Diode Laser Systems, include model: CureLight F2-A15 and CureLight F2-A30, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

    (2) The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

    The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

    Device Description

    The "CureLight Medical Diode Laser Systems", include model: CureLight F2-A15, CureLight F2-A30, CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60. Which consist of three main components:

    (1) Main device;
    (2) Foot switch;
    (3) Accessories.

    Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

    The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810/980nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the PHOMED'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

    MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

    AI/ML Overview

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