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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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