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510(k) Data Aggregation

    K Number
    K251094
    Device Name
    Alma Veil
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2025-05-06

    (26 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: The Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae. The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris. The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments. 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
    Device Description
    The Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse 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 fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (up) and/or (down) button. The selectable fluence values are 2 to 300 J/cm² at 1064 nm and 1.8 to 42 J/cm² at 532 nm.
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    K Number
    K243929
    Device Name
    Oligio X
    Manufacturer
    WON TECH Co., Ltd.
    Date Cleared
    2025-01-21

    (32 days)

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

    WON TECH Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.
    Device Description
    Oligio X is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 200 W. Oligio X consists of a main body including touch LCD monitor, a RF handpiece, return pads, a return pad cable, non-sterile treatment tips, cooling fluids, footswitch and a power cable. Oligio X RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. Oligio X delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.
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    K Number
    K241406
    Device Name
    Lavieen
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2024-06-28

    (42 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
    Device Description
    Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
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    K Number
    K241144
    Device Name
    Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2024-06-24

    (60 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICOCAREMAJESTY is indicated for the following at the specified wavelength: · 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black,brown, green, blue and purple. · 532 nm: Removal of tattoos for Fitzpatrick skin types I · III to treat the following tattoo colors: red, yellow and orange. · Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
    Device Description
    The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) 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 fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2. The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm
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    K Number
    K234104
    Device Name
    PICOANDY (Q-Switched Nd:YAG Laser)
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2024-03-15

    (80 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICOANDY is indicated for the following at the specified wavelength: · 1064 mm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. · 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. · Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
    Device Description
    The PICOANDY 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, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) 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.
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    K Number
    K240313
    Device Name
    Oligio X
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2024-02-22

    (20 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.
    Device Description
    Not Found
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    K Number
    K240064
    Device Name
    Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2024-02-07

    (29 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The Hair Boom Air diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
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    K Number
    K232106
    Device Name
    Air Gap Fiber
    Manufacturer
    WON TECH Co., Ltd.
    Date Cleared
    2024-01-08

    (178 days)

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

    WON TECH Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.
    Device Description
    The WONTECH Air Gap Fibers are available in 3 sizes. These are 272, 365 and 550 microns and designated as hard clad silica material. These sizes refer to the core diameters of the silica. All fibers are Low OH (hydroxide), especially adapted to delivering wavelengths of laser that are highly absorbed by water. However, for those wavelengths in which water absorption is not a limiting factor, Low OH fiber optic cables may be used as well. The fiber assemblies are configured with standardized SMA-905 connectors, which are the most commonly found connectors in use today. These Air Gap fibers are packaged in sterile, single use, peel away pouches for direct use in operating theaters. The Air Gap fibers are indicated for soft and hard tissue contact and prepared with a polished, flat distal end. The Air Gap fibers is standardized at 3 meters. These Air Gap Fibers may be used with laser outputs from 1-120 watts. The Air Gap Fibers are intended for use in laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable.
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    K Number
    K223727
    Device Name
    Lavieen
    Manufacturer
    Won Tech Co., Ltd.
    Date Cleared
    2023-08-25

    (255 days)

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

    Won Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (sun spots) and ephelides (freckles).
    Device Description
    Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
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    K Number
    K231054
    Device Name
    V-Laser
    Manufacturer
    WON TECH Co., Ltd.
    Date Cleared
    2023-08-14

    (123 days)

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

    WON TECH Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikloderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The V-Laser is also indicated for the treatment for pseudofolliculitis barbae. The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vasularity is an integral part of the scar. The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as harr removal and vascular lesions; and to reduce the potential side effects of laser treatments. 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
    Device Description
    The V-Laser is a Nd: YAG laser operating at wavelengths of 1,064 nm and 532 mm. The V-Laser consists of the main body, optical fiber cable, user handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse 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 fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (+ (up) and/or == (down) button. The selectable fluence values are 2 to 300 J/cm2 at 1064 nm and 1.8 to 42 J/cm2 at 532 mm.
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