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IRIS Q-switched Nd : YAG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength: Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign 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

The IRIS Q-Switched Nd: YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using different Handpiece able to control various treatment fluence.

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 lamp : Xe-gas contains high pressure lamp to increase specific laser beam

This converted light energy creates the Nd: Y AG 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

This device has optional 180mm Dye Hand Pieces to able to switch to 585nm or 650nm from 532nm.

This document is a 510(k) summary for the BM.IRIS Q-Switched Nd:YAG laser system. It asserts substantial equivalence to a predicate device, K113588 Spectra Nd:YAG Lutronic Corp, and refers to manufacturing in accordance with several standards. However, it explicitly states that clinical data is not required in this submission. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies.

Specifically, the document states on page 4:
"Clinical data is not required in this submission, but manufactured in accordance with below both mandatory and voluntary standards, performance test data attached."

Given this, I cannot provide the detailed information requested in your prompt as the submission itself indicates that clinical performance data was not a required component for this 510(k) clearance.

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