Search Results

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

Not Found

I'm sorry, but this document (K171443) is a 510(k) premarket notification letter from the FDA regarding the Vydence Etherea MX device. It primarily lists the indications for use of various handpieces with the device and confirms its substantial equivalence to previously marketed devices.

This document does not contain information about:

• Acceptance criteria tables
• Device performance data or reported results against acceptance criteria
• Details of a study proving the device meets acceptance criteria (e.g., sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details).

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a study report or clinical trial summary.

Ask a specific question about this device

Intense Pulsed Light (IPL-sq):

• Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles).
• Lentigines, nevi, and café-au-lait macules.
• The treatment of 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, and venous malformations.
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction.

Infrared (Intense IR):
Topical heating for the purpose of elevating tissue's temperature 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 of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Laser Nd:Yag 1064nm (1064 LongPulse):

• Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus;
• Non ablative treatment of facial wrinkles, scars and striae;
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction;
• Treatment of pseudofolliculitis barbae.

Not Found

The provided text is a 510(k) summary for a medical device called "Etherea," but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

A 510(k) submission typically demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial might. The document lists the indications for use of the Etherea device, which uses Intense Pulsed Light (IPL-sq) and Laser Nd:Yag 1064nm (1064 LongPulse) technologies for various dermatological and cosmetic treatments.

To answer your request, I would need a document specifically detailing performance studies and acceptance criteria for this device. The current document is a regulatory clearance letter and an "Indications for Use" statement.

Ask a specific question about this device