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    K Number
    K220041
    Device Name
    HandPICO
    Date Cleared
    2022-05-05

    (120 days)

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

    Vydence Medical Industria E Comercio Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, 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 cafè-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, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair to effect stable long-term or permanent hair 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 Fitzpatrick skin types 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 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, 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 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 esions 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, 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 tissue temperature. It's also indicated for 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 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); Cafe-au-lait macules; Sebortheic 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; 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, rosaceal diffiuse 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 perioral wrinkles. For use on all skin types (Fitzpatrick I-VI), including tanned skin. 1064nm Long Pulse Handpiece - Onychomycosis: podiatry (i.e. ablation, vaporization, 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; sebortheic 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; 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; Keratose; 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 1340 ProDeep Handpiece: fractional laser handpiece is intended for use in skin resurfacing; collimated laser handpiece is intended for the treatment of fine lines and wrinkles; treatment of atrophic acne scars; 755nm Fiber Delivered Handpiece (Zye and One) 755nm: 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, 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 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
    Device Description
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    K Number
    K202998
    Device Name
    Vydence Zye and Vydence One
    Date Cleared
    2021-10-26

    (390 days)

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

    Vydence Medical Industria E Comercio Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, 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 cafè-aulait macules. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair 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 Fitzpatrick skin types 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 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, 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 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 esions 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, 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 tissue temperature. It's also indicated for 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 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); Cafe-au-lait macules; Sebortheic 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 - · 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, rosaceal diffiuse 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 perioral wrinkles. - · For use on all skin types (Fitzpatrick I-VI), including tanned skin. 1064nm Long Pulse Handpiece - Onychomycosis · podiatry (i.e. ablation, vaporization, 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; sebortheic 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; - · 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; Keratose; 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 1340 ProDeep Handpiece · fractional laser handpiece is intended for use in skin resurfacing · collimated laser handpiece is intended for the treatment of fine lines and wrinkles; treatment of atrophic acne scars; 755nm Fiber Delivered Handpiece (Zye and One) 755nm • 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, 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 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
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    K Number
    K190007
    Device Name
    Vydence Laser Family
    Date Cleared
    2019-03-01

    (58 days)

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

    Vydence Medical Industria E Comercio Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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, 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 cafè-aulait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair 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 Fitzpatrick skin types 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, poikiloderma of Civate, 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 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, 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 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, 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 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, poikiloderma of Civate, leg veins and venous malformations; · removal of unwanted hair, for stable long term or 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 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 tissue temperature. It's also indicated for 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 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 tvpes, 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 Spider veins; Poikiloderma of Civatte; Angiomas · Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic 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 - · 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, rosaceal diffiuse 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 perioral wrinkles. - · For use on all skin types (Fitzpatrick I-VI), including tanned skin. 1064nm Long Pulse Handpiece - Onychomycosis · podiatry (i.e. ablation, vaporization, 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., dermatophyton 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 (sun lentigos (sun spots); cafe-au-lait macules; sebortheic 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; - · 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 Handed 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; Keratose; 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 1340 ProDeep Handpiece · non-ablative laser handpiece is intended for use in skin resurfacing 755nm Fiber Delivered Handpiece (Zye and One) 755nm • 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; treatment of benign pigmented lesions; treatment of wrinkles; photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias. 1064nm Fiber Delivered Handpiece (Zye and One) In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lessons 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 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-V), 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.).
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    K Number
    K171443
    Device Name
    Etherea MX
    Date Cleared
    2018-04-20

    (339 days)

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

    Vydence Medical Industria E Comercio Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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, 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 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, poikiloderma of Civatte, leg veins and venous malformations. · The removal of unwanted hair to effect stable long-term or permanent hair 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 Fitzpatrick skin types 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, 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 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 esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). · The treatment of face and body 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 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. 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, 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 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 and strains, and minor muscular back pain. 1064 LongPulse Handpiece · removal of unwanted hair, for stable long term or permanent hair reatment 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 1064 LongPulse Handpiece (continued) · Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic 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 1064 LongPulse Handpiece Short Pulse Operation · intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosaceal 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 perioral wrinkles. - · For use on all skin types(Fitzpatrick I-VI), including tanned skin. 1064 Handpiece - Onychomycosis · podiatry (i.e. ablation, vaporization, 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., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.). Acroma QS 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 (sun 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; - · 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. Acroma QS handpiece (continued) The 532 nm wavelength is indicated for: · incision, excision, ablation, vaporization of soft tissue; · tattoo removal: light blue, yellow, red; green; · benignvascular 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 - non-fractional · 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; 2940 DualMode Handpiece (continued) · PODIATRY Treatment of: Warts, plantar verrucae, large mosaic verrucae. Matrixectomy. 2940 DualMode Handpiece - fractional · skin resurfacing 1340 ProDeep Handpiece · non-ablative laser handpiece is intended for use in skin resurfacing
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