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The Secret MAX DEEPLUS MENU and SMARTCURE MENU are intended use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The WAVPLUS MENU is intended for the treatment of the following medical condition; using the handpiece for delivery of non-thermal RF energy combined with massage;

· Relief of minor muscle aches and pain, relief of muscle spasm

· Temporary improvement of local blood circulation

· Temporary reduction in the appearance of cellulite

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Secret MAX Multi-platform RF System", outlining its regulatory status and intended use. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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The SUPER VELOCE and Accessories are indicated for use in surgical, aesthetic, and cosmetic applications requiring selective photothermalysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

• · Mild to moderate inflammatory and pustular inflammatory acne vulgaris.(420nm filter, 560mm filter) · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm filter, 560nm filter)
  · The treatment of cutaneous lesions including warts, scars and striae; (515nm filter)
  · 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; (560nm filter, 590nm filter)
  · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction(590mm filter, 640nm filter, 695nm filter)
  · Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, the temporary relief of min associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, and strains, and minor muscular back pain. (800nm filter)
  The integral thermo-electric cooler is incoaling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
  · Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
  · Reduce discomfort during and/or associated with light or laser treatment:
  · Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
  • Allow the use of higher light or laser fluences for light or laser treatments (such as for hair reatment of vascular or pigmented lesions): and
  · Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

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This document (K241699) is an FDA 510(k) clearance letter for the "Super Veloce" device. It outlines the regulatory classification and general controls applicable to the device, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

510(k) clearances typically do not include detailed performance study results or acceptance criteria within the clearance letter itself. Instead, the manufacturer submits this information to the FDA as part of their 510(k) application, and the FDA evaluates it to determine substantial equivalence. The clearance letter only states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the specific performance study details of the device.

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The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

755nm Wavelength:

• Temporary hair reduction.
• Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
• Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
• Permanent hair reduction 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.
• On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions. Treatment of wrinkles.
• The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm Wavelength:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
• Permanent hair reduction 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.
• The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains. hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• The laser is indicated for pigmented 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.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.

The PENTO Nd: YAG and Alexandrite laser system in indicated for : the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

755nm Wavelength:

• Temporary hair reduction.
• Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
• Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
• Permanent hair reduction 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.
• On all skin types (Fitzpatrick I- VI) including tanned skin.
• Treatment of benign pigmented lesions. Treatment of wrinkles.
• The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm Wavelength:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
• Permanent hair reduction 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.
• The lasers are indicated on all skin types Fitzpatrick I- VI including tanned skin.
• Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains. hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• The laser is indicated for pigmented 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.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.

The provided FDA document is a 510(k) clearance letter for the PENTO Nd:YAG and Alexandrite laser system. It describes the device's intended use and substantial equivalence to a predicate device, but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML component.

Therefore, I cannot extract the requested information based on the input document. The document focuses on the regulatory clearance of a physical laser system, not on an algorithm's performance.

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