(25 days)
1064nm: The Cynosure YAG MIR II 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 lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, 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.
1320mm: The Cynosure YAG MIR II 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 and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.
1440nm: The Cynosure YAG MIR II 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 periorbital and perioral wrinkles and pigmented lesions.
The Cynosure Y AG MIR II laser is a Nd: Y AG laser, having a ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure YAG MIR II Laser does not include any acceptance criteria or a study proving the device meets them.
Instead, the summary states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
This indicates that the device's substantial equivalence to predicate devices was based on its similarity in intended use, principle of operation, and technical specifications (wavelengths and pulse energy range), rather than new performance data or clinical studies.
Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets them from the provided text.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.