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510(k) Data Aggregation

    K Number
    K260632

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-17

    (19 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252971

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    Manufacturer
    Date Cleared
    2026-03-17

    (181 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254197

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    Manufacturer
    Date Cleared
    2026-03-11

    (78 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253951

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    Date Cleared
    2026-03-06

    (86 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253920

    Validate with FDA (Live)

    Date Cleared
    2026-03-03

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253829

    Validate with FDA (Live)

    Date Cleared
    2026-02-27

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

    1064 nm
    The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

    532 nm
    The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

    Device Description

    The Medical Ultra-Pico Laser Treatment System is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, a light guide arm, a light guide arm tip, a spot regulator and a footswitch. The laser output is delivered to the skin through the light guide arm delivery system terminated by the light guide arm tip. The energy and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. For treatment, the user can select the appropriate frequency and the related output energy value by pressing plus and/or minus button from the LCD display/Touch Pad located on the front of the main unit.

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    K Number
    K253828

    Validate with FDA (Live)

    Date Cleared
    2026-02-27

    (88 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Alexandrite and Nd:YAG laser Therapy System is indicated for the following at the specified wavelength:

    755nm

    • Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.
    • Treatment of benign pigmented lesions.
    • Treatment of wrinkles.
    • The photocoagulation of dermatological benign vascular lesions (such as portwine stains, hemangiomas, telangiectasias)

    1064nm

    • Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis.
    • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
    • Treatment of wrinkles.
    • Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
    Device Description

    The Medical Alexandrite and Nd:YAG laser Therapy System is a Nd: YAG and Alexandrite laser operating at wavelengths of 1064 nm and 755 nm. The Medical Alexandrite and Nd:YAG laser Therapy System consists of the main unit, optical fiber, handpiece, treatment tip, footswitch, and handpiece holder and other accessories. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The Medical Alexandrite and Nd:YAG laser Therapy System is used for a variety of medical purpose. For treatment, the user can select the appropriate wavelength and the related output energy value by pressing UP and/or DOWN button from the LCD display/Touch Pad located on the front of the main unit.

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    K Number
    K254271

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    Device Name
    CAPRI
    Manufacturer
    Date Cleared
    2026-02-26

    (58 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,

    • Treatment of back acne
    • Treatment of atrophic acne scars
    • Treatment of facial wrinkles
    • Treatment of mild to moderate acne vulgaris
    • Treatment of Sebaceous Hyperplasia.
    Device Description

    CAPRI is a diode laser which delivers energy at a wavelength of 1450 nm and it is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue. Laser energy is delivered through an optical fiber that is attached to the handpiece. Laser guide tip is attached to the handpiece ensures that the spot is focused on the skin and serves as the laser beam aiming device.

    CAPRI consists of the following components:

    • Main Unit
    • Accessories:
      • Handpiece & Laser Guide Tip
      • Foot Switch
      • Remote Interlock Connector
      • Gas Spray (HFC-134)
      • Key Switch
      • Eye Protection Goggle
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    K Number
    K252599

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    Date Cleared
    2026-02-24

    (190 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation.

    Indications for Use:

    Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm):

    • Temporary hair reduction (Hair-Removal function).
    • Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function).

    Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm):

    • Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types I-VI).

    Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of a treatment regimen.

    Device Description

    The Diode Laser Therapy Systems, Model WLA-02, is a medical device intended for dermatological procedures requiring coagulation. It includes mixed and single wavelength handpieces designed for temporary and permanent hair reduction, as well as the treatment of benign vascular lesions. The system delivers controlled laser energy to target melanin or vascular structures while integrated cooling helps protect surrounding skin tissue. The system comprises:

    • Main Console: Includes power switch, handpiece holder, LCD touch screen, emergency shut-off, hand-grip grab bar, handpiece connector, access door, observation window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain, and cooling fans.
    • Treatment Handpiece: Incorporates laser aperture, laser emission indicator, laser emission system, and handpiece display screen.
    • Foot Switch: Activates laser emission.
    • Embedded Software: Diode Laser Therapy Systems Control Software.
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    K Number
    K252561

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    Device Name
    BTL-754FF
    Date Cleared
    2026-02-18

    (189 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BTL-754FF device with BTL-754-1 handpiece has the following indications for use:

    The BTL-754-1 with 2940nm is intended for use in Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).

    Laser skin resurfacing procedures for the treatment of:

    • Acne scars
    • Wrinkles

    The BTL-754-1 with 1540nm is intended to be used for incision, excision, ablation, and coagulation (hemostasis) of soft tissue. The device is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), for the treatment of periorbital and perioral wrinkles, for the treatment of back acne.

    The BTL-754-1 with combined 1540nm and 2940nm is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing, treatment of wrinkles and textural irregularities.

    BTL-754-4 handpiece has the following indications for use:

    The BTL-754-4 with 2940nm in Fractional mode is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

    The BTL-754-4 with 1540nm in Fractional mode 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 BTL-754-4 with combined 1540nm and 2940nm in Fractional mode 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.

    The BTL-754-4 with 1540nm in Macro mode is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

    Device Description

    The BTL-754FF is a medical device containing two laser wavelengths. The parameters of each wavelength can be adjusted individually. The device allows the separate application of these wavelengths or their combination. The laser radiation is generated by solid-state lasers and delivered using an articulated arm to an applicator. The laser radiation is applied to the patient's body in a different beam pattern, depending on the applicator used. The absorption of laser radiation in the tissue leads to tissue heating, ablation, or coagulation.

    The BTL-754FF consists of a main unit, articulated mirror arm and applicators. The main unit is equipped with a color touch screen with a wide view angle that makes the device easy to use. The on-screen 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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