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510(k) Data Aggregation

    K Number
    K250165
    Device Name
    Pastelle
    Manufacturer
    WONTECH Co., Ltd.
    Date Cleared
    2025-07-03

    (163 days)

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

    WONTECH Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma 1064nm in Genesis (long-pulse) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of Lentigines - Treatment of Café-au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and Nevi spilus
    Device Description
    The Pastelle laser system consists of an Nd:YAG laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains two Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed ,in the special adjustable holders composed the laser cavity.
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    K Number
    K251288
    Device Name
    Veincare
    Manufacturer
    WONTECH CO., LTD.
    Date Cleared
    2025-05-14

    (19 days)

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

    WONTECH CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
    Device Description
    The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
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    K Number
    K243957
    Device Name
    PICOALEX
    Manufacturer
    WONTECH CO., LTD.
    Date Cleared
    2025-03-12

    (79 days)

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

    WONTECH CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.
    Device Description
    The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.
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    K Number
    K241527
    Device Name
    Pastelle Pro
    Manufacturer
    Wontech Co., Ltd.
    Date Cleared
    2025-02-14

    (260 days)

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

    Wontech Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma 1064nm in Genesis (long-pulse) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of Lentigines - Treatment of Café-au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and Nevi spilus
    Device Description
    The Pastelle Pro laser system consists of an Nd: YAG laser head, a power supply, a cooling system and other electrical components. The laser head contains two Nd. YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Nd: YAG laser rod, causing the emission of a pulse of laser energy. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The basic frequency of 1064 nm can be doubled by a KTP crystal, which can be inserted to a working area. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 1064 nm. 532 nm and 660 nm. The output of the laser is delivered to the area of treatment through an Articulated Arm with a handpiece. A trigger (foot switch) controls the delivery of pulses. The user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.
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    K Number
    K241643
    Device Name
    WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
    Manufacturer
    WONTECH Co., Ltd
    Date Cleared
    2025-02-14

    (252 days)

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

    WONTECH Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 532nm - 2200mm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
    Device Description
    WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are indented for endovascular of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radially. Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement. WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W. They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.
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    K Number
    K241930
    Device Name
    Veincare
    Manufacturer
    Wontech Co., Ltd.
    Date Cleared
    2024-11-14

    (136 days)

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

    Wontech Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
    Device Description
    The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470mm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
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    K Number
    K191154
    Device Name
    Hair Boom 69
    Manufacturer
    Wontech
    Date Cleared
    2019-07-29

    (89 days)

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

    Wontech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopeda who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
    Device Description
    The Hair Boom 69 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
    K183156
    Device Name
    V-Laser
    Manufacturer
    WONTECH Co., Ltd.
    Date Cleared
    2019-04-24

    (160 days)

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

    WONTECH Co

    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.
    Device Description
    The V-Laser is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to 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. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
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    K Number
    K182562
    Device Name
    Hair Boom 69
    Manufacturer
    WonTech
    Date Cleared
    2018-11-16

    (59 days)

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

    WonTech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The Hair Boom 69 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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