Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K253342

    Validate with FDA (Live)

    Device Name
    PICO-K
    Manufacturer
    Date Cleared
    2025-12-24

    (85 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 PICO-K is intended for use in the following indications at the specified wavelength:

    1064 nm wavelength

    • Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
    • Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
    • Treatment of acne scars in Fitzpatrick Skin Types II-V
    • Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV

    532 nm wavelength

    • Tattoo removal in Skin Types I - III
    • Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
    Device Description

    The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Three different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, and MLA handpiece. Each handpiece integrates and aiming beam that shows the treatment area.

    The Nd:YAG laser surgical system employs a solid-state laser with a medium of Nd:YAG at 1064 nm and KTP at 532 nm. The energy from the 1064 nm wavelengths emitted by the laser is directed at the cells or tissues of the skin, raising the temperature of the targeted tissue according to the Selective Photothermolysis Theory. This selective heating of the tissue results in the cutting, destruction, or removal of the tissue through the heat energy produced by the laser.

    PICO-K employs a patented resonator design with optics aligned under controlled thermal lensing conditions. At high repetition rates (8–10 Hz), thermal lensing of the Nd:YAG rod can degrade beam quality in conventional systems. In PICO-K, the lamp frequency is fixed at 8–10 Hz, optical alignment is optimized under these conditions, and laser emission is generated only at divisor frequencies (1, 2, 3, 4, 5, 8, 9, 10 Hz).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K253344

    Validate with FDA (Live)

    Device Name
    BELLUS-Q
    Manufacturer
    Date Cleared
    2025-11-25

    (56 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

    BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

    1064 nm wavelength in Q-switched mode:

    • Removal of dark (black, blue, brown) tattoo ink
    • Treatment of nevus of ota
    • Treatment of common nevi
    • Removal and lightening of unwanted hair
    • Skin resurfacing procedures for the treatment of acne scars and wrinkles
    • Treatment of melasma
    • General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

    1064 nm wavelength in GENESIS mode:

    • Treatment of wrinkles
    • Treatment of mild to moderate inflammatory acne vulgaris

    532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):

    • Red, tan, purple and orange tattoo ink removal
    • Sky blue (light) tattoo ink removal
    • Green tattoo ink removal
    • Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
    • Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
    • Seborrheic Keratosis
    • Treatment of post-inflammatory hyperpigmentation
    • Skin resurfacing procedures for the treatment of acne scars and wrinkles
    • Removal of epidermal pigmented lesions
    Device Description

    The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates and aiming beam that shows the treatment area.

    The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications.

    The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1