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1064 nm: The Cynosure YAG Family laser is intended for the coagulation and hemostasis of bonion vascular lesions such as, but not limited to, port winc stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, stiae and psoriasis. The laser is also intended for the treatment of bonign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café' au lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or 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 indicated 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 pseudofolliculitis barbae (PFB).

1320 nm The Cynosure YAG Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

The Cynosure YAG Family Laser is a Nd: Y AG laser, having a Nd: Y AG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm and 1,320 nm. Laser activation is by foot switch or finger switch. Overall weight of the laser is 81 Kg, and the size is 112x48x71 cm (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.

The provided document is a 510(k) Summary for the Cynosure YAG Family Laser. It describes a medical device, but it does not contain any information about acceptance criteria or a study proving its performance against such criteria.

The 510(k) Summary explicitly states:

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

This means that no performance data, clinical or nonclinical, was submitted or reviewed for this 510(k) application to demonstrate the device meets any specific acceptance criteria. The device's approval is based on its substantial equivalence to predicate devices. The review process for substantial equivalence does not typically require new clinical or non-clinical performance data if the device is deemed sufficiently similar to already approved predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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