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510(k) Data Aggregation

    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
    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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