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585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.

1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

585 - 600nm with 1,064mm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.

The Cynergy Multiplex laser is user selectable, multi wavelength laser, having both an organic dye and an Nd:YAG rod lasing medium. It is a pulsed dye laser with wavelengths of 585, 590, 595, 600 nm and an Nd:YAG laser with a wavelength of 1,064 nm. It is capable of delivering one wavelength pulse or mixing of two wavelengths pulse.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD).

Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

The provided text is a 510(k) summary for the Cynosure Cynergy Multiplex Laser, which is a medical laser system. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for novel performance claims.

Therefore, the document explicitly states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

Given this, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text. The regulatory submission relies on the established safety and effectiveness of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

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