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510(k) Data Aggregation

    K Number
    K243290
    Device Name
    BTL-785MJ
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2025-05-09

    (203 days)

    Product Code
    NUW, NFO
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTL-785MJ device with the controller and single-use applicators has the following indications for use: 1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2. Muscle re-education 3. Increasing blood flow 4. Maintain or increase mandibular range of motion
    Device Description
    The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion. The BTL-785MJ device consists of the following main components: - Main unit - Handpiece - Holding arm - Connection cables - Single-use applicators - Therapy discomfort button
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    K Number
    K241516
    Device Name
    BTL-398
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2025-02-10

    (257 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
    Device Description
    The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.
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    K Number
    K241270
    Device Name
    BTL-754
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2025-01-30

    (269 days)

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

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTL-754 device with BTL-754-4 handpiece has the following indications for use: The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. The combined 1540mm and 2940mm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
    Device Description
    The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate light in the visible or invisible part of the electromagnetic spectrum. The generation of radiation occurs by means of so-called stimulated emission, thanks to which its beam has specific properties - the laser beam is well directed and can propagate over long distances without much divergence. It can also be focused into a very small spot where a very high intensity is achieved. The BTL-754 consists of a main unit, articulated mirror arm and applicator. The main unit is equipped with a color touch screen with a wide that makes the device easy to use. The onscreen information informs the operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about therapy parameters. The device is equipped with the Emergency laser stop button for immediate termination of the laser emission.
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    K Number
    K242532
    Device Name
    BTL-785BNF-E
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2024-12-13

    (109 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for aesthetic use including facial and neck or body skin stimulation.
    Device Description
    The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use. The main control unit is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, the remaining therapy time and the main therapy parameters on the screen. The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face. The device consists of the following main components: BTL-785 main unit, BTL-785-7 Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.
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    K Number
    K233849
    Device Name
    BTL-499
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2024-04-23

    (140 days)

    Product Code
    GEI, PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BTL-499 is indicated to be used for: Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-499 is intended for use with skin types I - VI. Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under. The BTL-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The BTL-499 is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
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    K Number
    K233604
    Device Name
    BTL-785S
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2024-03-28

    (140 days)

    Product Code
    GEI, PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTL-785S device has the following indications for use: The BTL-785S with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785S with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785S with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785S device used with tips BTL-785-4-3, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators: BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide: - Heating for the purpose of elevaing tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide: - Non-invasive temporary reduction of facial wrinkles. BTL-785-7-9 single-use applicator is intended to: - Affect the appearance of lax tissue in the submental area.
    Device Description
    The BTL-785S is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785S device comes with five different types of applicators. The BTL-785S device consists of the following main components: - microprocessor-driven control unit - radiofrequency generator - user interface with 15.6" color touch screen - applicators - exchangeable applicator tips
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    K Number
    K190456
    Device Name
    BTL 799-2L
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2019-07-05

    (130 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BTL 799-2L is indicated to be used for: - · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - · Strengthening, Toning and Firming of buttocks, thighs and calves. - · Improvement of muscle tone and firmness, for strengthening muscles in arms.
    Device Description
    The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has two outputs that enable simultaneous treatment by two applicators. The BTL 799-2L is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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    K Number
    K190023
    Device Name
    BTL-084
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2019-03-29

    (84 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTL-084 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-084 massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The BTL-084 is a non-invasive therapeutic device enables the application of therapy by a high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. The energy flow is indicated by the illuminated treatment tip. The BTL-084 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, massage generator, user interface with 8.4" color touch screen, handpiece.
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    K Number
    K182363
    Device Name
    BTL-703
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2019-01-24

    (147 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
    Device Description
    The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.
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    K Number
    K180359
    Device Name
    BTL-FR2000
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2018-12-13

    (307 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTL Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.
    Device Description
    The BTL-FR2000 device enables application of therapy by a high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with button, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip. The BTL-FR2000 device comes with two types of the applicator, depending on the applicator tip attached - Applicator 786-1 and Applicator 786-2. The BTL-FR2000 device consists of the following main components: - microprocessor-driven control unit - radiofrequency generator - user interface with 8.4" color touch screen - applicator for an application of radiofrequency - exchangeable applicator tips
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