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Lucas Plus Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for Coagulation and hemostasis.

532nm Wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles, Treatment of Post Inflammatory Hyperpigmentation (PIH)

1064nm Wavelength:

Tattoo removal: dark ink (black, blue, green ) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Lucas Plus Nd : YAG Laser System." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

While it lists the indications for use of the laser system, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to clinical trials or performance evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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