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    F3606, F2210 Pro, F5808, INIAED001, INIA-ED002, INIA-BLD001, E1507)
    Regulation Number: 21 CFR 878.4810
    relief
    Regulatory Class: II
    Product Code: OHS, OLP, NFO
    Regulation Number: 21 CFR 878.4810
    relief
    Regulatory Class: II
    Product Code: OHS, OLP, NFO
    Regulation Number: 21 CFR 878.4810

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:

    Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.

    1. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
    2. The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

    Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:

    Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.

    1. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
    2. The Photon mode: The red light is intended for the treatment of periorbital wrinkles.
    Device Description

    Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging.

    The device is for home environment use, which has electrodes for microcurrent stimulation (the microcurrent stimulation mode was cleared under K252553) and light emitting diodes for light therapy treatment. Especially, the light therapy function of the device equips both red light (for wrinkles treatment) and blue light (for acne treatment) for model INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, while equips only red light for model INIA-ED001, INIA-ED002, INIA-BLD001, E1507.

    To use the device, user should place the treatment head on the face and body (only applicable for microcurrent stimulation mode). The device will automatically shut down after treatment time is over.

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    K Number
    K251981

    Validate with FDA (Live)

    Date Cleared
    2026-01-30

    (217 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Re: K251981
    Trade/Device Name: Boston PICO (Boston PICO)
    Regulation Number: 21 CFR 878.4810
    dermatology.

    • Regulation Medical Specialty: General & Plastic Surgery
    • Regulation Number: 878.4810
      dermatology.
    • Regulation Medical Specialty: General & Plastic Surgery
    • Regulation Number: 878.4810
      dermatology.
    • Regulation Medical Specialty: General & Plastic Surgery
    • Regulation Number: 878.4810
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:

    1064 nm wavelength:

    • Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
    • Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

    532 nm wavelength:

    • Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
    • Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

    Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

    Device Description

    The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

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    K Number
    K252603

    Validate with FDA (Live)

    Date Cleared
    2026-01-28

    (163 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    **
    Trade/Device Name: HIGHERDOSE Body Sculptor (Model: GS-03)
    Regulation Number: 21 CFR 878.4810
    -03)
    Review Panel: General & Plastic Surgery
    Product Code: OHS
    Regulation Number: 878.4810
    K223893
    Review Panel: General & Plastic Surgery
    Product Code: OHS
    Regulation Number: 878.4810
    K250532
    Review Panel: General & Plastic Surgery
    Product Code: OHS
    Regulation Number: 878.4810
    Review Panel: General & Plastic Surgery
    Product Code: OHS, OLP
    Regulation Number: 878.4810

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.

    Device Description

    The HIGHERDOSE Body Sculptor (Model: GS-03) is a home-use light-emitting diode phototherapy device with two proven wavelengths of light 650nm Red light and 850nm Near infrared red light, both of these lights are known to reducing the wrinkle.

    The main device is made of black plastic (ABS+PC) and silicone button cup, and contain light emitting diode (LED) which will emit red light and infrared light. The device is a handheld device.

    The device contains a rechargeable Lithium battery, which can be charged by charging disk. The HIGHERDOSE Body Sculptor cannot be operated while charging.

    Press and hold the power button to turn the product on/off. Press the power button briefly to turn the LED light therapy on/off.

    The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

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    K Number
    K252753

    Validate with FDA (Live)

    Date Cleared
    2026-01-24

    (148 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    California 95825

    Re: K252753
    Trade/Device Name: Vydence Family of Lasers
    Regulation Number: 21 CFR 878.4810
    in dermatology |
    | Classification Name | Powered Laser Surgical Instrument |
    | Regulation Number | 878.4810

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IPL 390nm-510nm Filter

    • The treatment of inflammatory acne (acne vulgaris);
    • The treatment of leukoderma, including vitiligo (acquired leukoderma).

    IPL 400nm-1200nm Filter

    • The treatment of moderate inflammatory acne vulgaris;
    • The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles);
    • The treatment of benign cutaneous lesions including warts, scars and striae;
    • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins and venous malformations.
    • Use on all skin types (Fitzpatrick I-VI).

    IPL 515-1200nm Filter

    • The treatment of moderate inflammatory acne (acne vulgaris).
    • The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and café-au-lait macules.
    • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
    • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth 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.
    • Use on all skin types (Fitzpatrick I-V).

    IPL 540nm-1200nm Filter

    • Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
    • Lentigines, nevi, and cafe-au-lait macules;
    • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
    • The treatment of benign cutaneous lesions including warts, scars and striae.
    • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth 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.
    • Use on all skin types (Fitzpatrick I-VI).

    IPL 540nm-1200nm Filter

    • Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
    • lentigines, nevi, and cafe-au-lait macules;
    • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
    • The treatment of benign cutaneous lesions including warts, scars and striae.
    • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair growth 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.
    • Use on all skin types (Fitzpatrick I-VI).

    IPL 580nm-1200nm Filter

    • The treatment of moderate inflammatory acne vulgaris.
    • The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
    • The treatment of face and body benign vascular and benign pigmented lesions.
    • The treatment of benign cutaneous lesions, including scars and striae.
    • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
    • The removal of unwanted hair to effect stable long-term or permanent hair reduction.. Permanent reduction in hair growth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.
    • Use on all skin types (Fitzpatrick I-VI).

    IPL 640nm-1200nm Filter

    • The treatment of tattoos;
    • The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;
    • The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait;
    • The treatment of benign cutaneous lesions including warts, scars and striae;
    • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
    • 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 if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regimen).
    • Use on all skin types (Fitzpatrick I-VI), including tanned skin.

    IPL 695nm-1200nm Filter

    • 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 if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen).
    • Use on all skin types (Fitzpatrick I-VI), including tanned skin

    Intense IR Handpiece
    Intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. It's also indicated for the treatment in the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

    1064nm Long Pulse Handpiece

    • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime
    • Treatment of pseudofolliculitis barbae (PFB)
    • Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
    • Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Café-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags, keratoses, the removal of black, blue, or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos), plaques
    • Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis
    • 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 non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
    • Laser skin resurfacing procedures for the treatment of: Acne scars, wrinkles
    • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;

    1064nm Long Pulse Handpiece - Short Pulse Operation

    • Intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.
    • Is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioralwrinkles.
    • For use on all skin types (Fitzpatrick I-VI), including tanned skin.

    1064nm Long Pulse Handpiece - Onychomycosis

    • Podiatry (i.e. ablation, vaporization, incision, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,
    • Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).

    Acroma Handpiece
    The 1064 nm wavelength is indicated for:

    • Treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas;
    • Benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;
    • Benign pigmented lesions such as, but not limited to: lentigos (age spots); solar lentigos (sun spots); cafe-au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags; keratoses; the removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques;
    • Pigmented benign lesions to reduce lesions' 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 non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles; perioral wrinkles;
    • Laser skin resurfacing procedures for the treatment of acne scars; wrinkles,
    • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
    • Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

    The 532 nm wavelength is indicated for:

    • Incision, excision, ablation, vaporization of soft tissue;
    • Tattoo removal: light blue, yellow, red; green;
    • Benign vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi;
    • Benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi;
    • Other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques

    1540 GoSmooth Handpiece

    • The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

    2940 DualMode Handpiece
    Dermatology and Plastic Surgery:

    • Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins;
    • Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; Diagnostic biopsies; Decubitus ulcers;
    • Podiatry
    • Treatment of warts, plantar verrucae, large mosaic verrucae
    • Matrixectomy

    2940 DualMode Fractional

    • Skin Resurfacing

    1340nm ProDeep Handpiece

    • Non-ablative laser handpiece is intended for use in skin resurfacing

    ProDeep 6mm collimated handpiece:

    • Treatment of fine lines and wrinkles, Treatment of atrophic acne scars, Treatment of mild to moderate inflammatory acne vulgaris

    755nm Fiber Delivered Handpiece
    755nm Handpiece (Zye and One)

    • Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. 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; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas and spider angiomas, poikiloderma of Civatte and superficial venous malformations.

    1064nm Fiber Delivered Handpiece (Zye and One)

    • In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for 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 if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin.
    • In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
    • In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;"

    HandPICO Handpiece
    532nm (pico-second):

    • Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange;
    • Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

    1064nm (pico-second):

    • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

    532nm (nano-second):

    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
    • Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III

    1064nm (nano-second):

    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-VI
    • Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI

    The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:

    • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
    • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
    • Treatment of acne scars in Fitzpatrick Skin Types II-V.
    • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.

    The Zye Ultra is indicated for:
    755 nm:
    Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. 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; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation, melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas and spider angiomas poikiloderma of Civatte and superficial venous malformations.

    1064nm
    In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas, hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for 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 if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin.

    • In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
    • In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;"
    Device Description

    The Vydence Family of Lasers consists of five models of configurable platforms that include up to nine different handpieces. The Vydence Family has multiple modalities including IPL and IR handpieces. In addition, there is a variety of different wavelength laser handpieces including 1064nm, 532nm, 1540nm, 2940nm, 1340nm and 755nm.

    The Zye Ultra model has a feature that includes a blended mode which emits 755 nm Alex and 1064nm Nd:YAG laser energy sequentially

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    K Number
    K253633

    Validate with FDA (Live)

    Date Cleared
    2026-01-24

    (66 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K253633**
    Trade/Device Name: Holmium Laser Therapeutic Apparatus (HZ-40)
    Regulation Number: 21 CFR 878.4810
    Instrument for Use in General and Plastic Surgery and in Dermatology |
    | Regulation Number | 21 CFR 878.4810
    Co., Ltd. | Quanta System SPA | Asclepion Laser Technologies Gmbh | / |
    | Regulation Number | 21 CFR 878.4810
    | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
    | Regulation Name | Laser Surgical Instrument For Use In

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Holmium Laser Therapeutic Apparatus are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and stone fragmentation in use in medical specialties including: Urology, Gastroenterology, ENT, Gynecology and general surgery.

    Device Description

    The HZ-40 Holmium Laser Therapeutic Apparatus is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, door interlock, and real-time monitoring of laser output.

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    K Number
    K253712

    Validate with FDA (Live)

    Date Cleared
    2026-01-23

    (60 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
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    510k Summary Text (Full-text Search) :

    051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
    Regulation Number: 21 CFR 878.4810
    Light Based Laser For Acne(OLP), Infrared, Therapeutic Heating(ILY)
    Regulation number: 21 CFR 878.4810

    Page 6

    Page 2 of 12

    Product CodeOHS, OLP, ILY
    Regulation Number21 CFR 878.4810
    21 CFR 890.550021 CFR 878.4810 21 CFR 890.5500
    21 CFR 878.481021 CFR 878.4810 21 CFR 890.5500
    Regulation NameLight Based Over The
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    *Red+Infrared light: Treatment of full-face wrinkles.
    *Red light: Treatment of full-face wrinkles.
    *Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    *Blue light: Treatment of mild to moderate inflammatory acne.
    *Red+Blue light: Treatment of mild to moderate inflammatory acne.
    The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

    Device Description

    LED Light Therapy Mask (Model: RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Mask is consisting of main unit(mask), controller, Type-C charging cable and so on. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 465nm), Infrared light (wavelength 850nm). All models can output 5 kinds of treatment modes: red+infrared, red, infrared, blue and red+blue light.

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    K Number
    K252369

    Validate with FDA (Live)

    Device Name
    Boston Pico755
    Date Cleared
    2026-01-21

    (175 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
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    510k Summary Text (Full-text Search) :

    Delaware 19803

    Re: K252369
    Trade/Device Name: Boston Pico755
    Regulation Number: 21 CFR 878.4810
    Regulation Medical Specialty: General & Plastic Surgery
    Regulation Number: 878.4810
    **Product
    Regulation Medical Specialty: General & Plastic Surgery
    Regulation Number: 878.4810
    **Product

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

    Device Description

    The Boston Pico755 is a medical solid-state laser equipment which is indicated for the removal of tattoos and benign pigmented lesions, including but not to limited to: Ota nevus, Hori spots (Hori nevus) and melasma. It has handpieces for the treatment of acne scars and wrinkles in skin types I-IV. The device is intended to be used in professional healthcare facilities by trained physicians only.

    The subject device Boston Pico755 consists of main unit (including power module, laser module, control system and cooling system), a light guide articulated arm, a footswitch, a handpiece and protective Glasses. It is connected to supply mains directly through undetachable power cord and plug. There are 8 types of replaceable handpieces - Zoom S, Zoom X, M, M6, M8, M10, 755x, 755s, and operators can choose the appropriate handpiece according to treatment needs.

    When the system automatically detects the model of the installed handpiece, it will display the corresponding treatment interface specific to that handpiece. Users can view or adjust relevant parameters such as wavelength, fluence, energy, spot size, and repetition rate directly from the interface.

    After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Footswitch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. The cooling system controls the heating caused by the laser output.

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    K Number
    K253881

    Validate with FDA (Live)

    Date Cleared
    2025-12-29

    (25 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
    Regulation Number: 21 CFR 878.4810
    and in dermatology
    Regulatory Class: II
    Product Code: OHT
    Regulation Number: 21 CFR 878.4810
    Technology Co., Ltd | Shenzhen Ulike Smart Electronics Co.,Ltd. | / |
    | Regulation number | 21 CFR 878.4810
    | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
    | Product code | OHT | OHT | OHT | Same |

    Page 9

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair.

    Device Description

    Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) are a small over-the-counter device for the removal of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the power adapter and its IPL emission activation is by a switch or auto light emission.

    Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

    Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

    All models have single pulse, dual pulse and three pulse functions.

    The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

    The device is intended to be used for adults aged over 18.

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    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
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    Why did this record match?
    510k Summary Text (Full-text Search) :

    Republic Of Korea

    Re: K253342
    Trade/Device Name: Pico-k
    Regulation Number: 21 CFR 878.4810
    |
    | Device Classification Name | Powered laser surgical instrument |
    | Regulation Number | 21 CFR § 878.4810
    |
    | Device Classification Name | Powered laser surgical instrument |
    | Regulation Number | 21 CFR § 878.4810
    StarWalker | PICOHI | - |
    | Product Code | GEX | GEX | GEX | Identical |
    | Regulation Number | 21 CFR 878.4810
    | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
    | 510(k) Review Panel | General & Plastic Surgery

    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).

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    K Number
    K253400

    Validate with FDA (Live)

    Date Cleared
    2025-12-24

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    , FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
    Regulation Number: 21 CFR 878.4810
    Dermatology
    Regulatory Class: II
    Product Code: OHS, OLP, ILY
    Regulation Number: 21 CFR 878.4810
    Intellectual Properties, LLC | Beijing ADSS Development Co., Ltd. | / |
    | Regulation number | 21 CFR 878.4810
    | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
    | Product code | OHS, OLP, ILY | OHS,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    a. Red light: Treatment of full-face wrinkles.
    b. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness, promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
    c. Amber light: Treatment of full-face wrinkles.
    d. Blue light: Treatment of mild to moderate inflammatory acne.

    Device Description

    The subject device LED LIGHT THERAPY FACE MASK is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes.

    The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and USB charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.

    The LEDs generate 4 kinds of light which include 460nm±5nm blue light, 630±5nm and 660nm±5nm red light, 850±5nm near-infrared light, 605±5nm amber light. A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED mode output. And the straps used for securing the mask unit to the body part.

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