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510(k) Data Aggregation

    K Number
    K242755
    Device Name
    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
    Manufacturer
    Gigaalaser Company Ltd.
    Date Cleared
    2025-05-19

    (249 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B 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 Medical Diode Laser Systems, model: VELASⅡ-30B is 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 Medical Diode Laser Systems, model: VELASⅡ-30B is 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 "Medical Diode Laser Systems", include model: VELASⅡ-30B, VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B which consist of three main components: Main device; Foot switch; 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 810nm and/or 980nm+/-10nm (pilot beam: 650nm+/-10nm). 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 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.
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    K Number
    K231997
    Device Name
    SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
    Manufacturer
    Cure Point Therapeutics, Inc.
    Date Cleared
    2024-10-15

    (468 days)

    Product Code
    ILY, PDZ
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Product Code ILY - 810 and 980 nm wavelength: The SIRONA 100 Therapy Laser System emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. Product Code PDZ - 980 nm wavelength: The SIRONA 100 Therapy Laser System is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophyton rubrum and T. mentagrophytes, and/ or yeasts Candida albicans, etc.
    Device Description
    Not Found
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    K Number
    K223642
    Device Name
    LED Lip Perfector, model: ZC-05
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-03-09

    (93 days)

    Product Code
    ILY, OHS
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.
    Device Description
    The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).
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    K Number
    K221189
    Device Name
    OLIZ LTB-1000A
    Manufacturer
    LTBIO Co., Ltd.
    Date Cleared
    2022-08-29

    (126 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OLIZ LTB-1000A is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of min, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    Device Description
    The OLIZ LTB-1000A is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light. OLIZ LTB-1000A produces light in the near infrared region of the spectrum (850nm) intended to provide topical heating for temporary pain relief. This device provides a soothing vibration function for the purpose of enhancing the user's satisfaction.
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    K Number
    K213524
    Device Name
    CytonPro-5000
    Manufacturer
    Cytonsys Inc
    Date Cleared
    2022-08-10

    (280 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.
    Device Description
    The CytonPro-5000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.
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    K Number
    K202028
    Device Name
    dermalux Flex MD
    Manufacturer
    Aesthetic Technology Ltd
    Date Cleared
    2020-12-16

    (147 days)

    Product Code
    ILY, GEX, OHS, OLP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.
    Device Description
    The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected, through selecting various wavelength combinations. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.
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    K Number
    K171087
    Device Name
    AXON IR Heat Lamp
    Manufacturer
    Crystal Medtech, LLC
    Date Cleared
    2017-07-07

    (86 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXON IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    The AXON IR Heat Lamp System is intended for use as a therapeutic heat lamp. The System is a non-invasive device that emits light energy to the skinsurface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The AXON IR Heat Lamp System deliver invisible laser light beams at 810 and 915 nm wavelengths using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic green laser guide light with 3 mW of power. TThe System consists of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable. The control consoles are made of standard medical PVC material and are designed to be placed in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display. The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of qlass suitable for medical applications.
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    K Number
    K163079
    Device Name
    HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
    Manufacturer
    HealthLight, LLC
    Date Cleared
    2017-06-13

    (222 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.
    Device Description
    Not Found
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    K Number
    K170068
    Device Name
    Softcure 96
    Manufacturer
    WELLRAY MEDICAL LASER, INC.
    Date Cleared
    2017-05-05

    (116 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Softcure TM 96 is intended to emit energy in the visible spectrum (red 635mm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
    Device Description
    The Wellray® Medical Laser Softcure™ 96 is a therapeutic device using wavelengths of monochromatic light produced by semiconductor laser diodes to treat a variety of musculoskeletal concerns. The Softcure ™ 96 is a portable and wearable, battery powered, software controlled device intended for use on the body such as the back, legs, chest, arms or other areas where therapeutic light may be beneficial. A flexible pad, drawing power through an electrical cable from a carry able battery pack, emits red (635nm) light by means of semiconductor laser diodes to the desired body area. The flexible pad is designed to conform to the contour of the treatment site providing uniform treatment dosage over nonplanar body physique. The semiconductor laser diodes are monitored for temperature and light output by a microprocessor and cooled by variable speed fans to ensure the optimum light output. The lasers are allowed to energize only when four separate failsafe monitoring systems sense that the flexible pad is brought into close contact with the user's body. These failsafe systems include capacitive proximity sensors, body temperature sensors, an ambient light sensor and reference voltage monitoring.
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    K Number
    K162590
    Device Name
    Bashan TDP Heat Lamp
    Manufacturer
    Chogqing YUHE Medical Instruments Co., Ltd.
    Date Cleared
    2017-02-14

    (151 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    ILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    Bashan TDP Heat Lamp is used to provide topical heating to the body. It is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 5 to 25 microns, 110 volt power, 250 watts. It includes timer, safety fuses.
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