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The LUCID O-PTP Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm with optional dye hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

Tattoo removal: dark ink ( black, blue, brown) 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

The LUCID O-PTP O-Switched Nd: Y AG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence.

this device is non-contacted mode and consists of main function,

laser tube ; placed in the mixed crystals of copper pipe to the heater and produces a laser beam,

Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

The provided text is a 510(k) summary for the LUCID Q-PTP / HWA 55 laser system. It explicitly states in section 6, "Performance test," that "Clinical and Non-Clinical performance test data was not provided in this submission."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such data is present in the provided document.

The document focuses on demonstrating substantial equivalence to a predicate device (K113588, Spectra Nd:YAG by Lutronic Corp) based on similar design, construction, energy rates, pulse duration, optional dye handpiece, cooling system, and intended use, as well as adherence to various safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1).

Without a performance study, it's impossible to provide the requested information such as acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader multi-case study results.

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