(43 days)
Elite MPX 755 nm:
The Elite MPX Laser system is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Elite MPX 1064 nm:
The Elite MPX laser system 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 warts, scars, 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, verruca, 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 indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliculitis (PFB).
XPL Handpiece:
The XPL Pulsed Light handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The Cynosure Elite MPX Laser System with XPL Handpiece is a solid state laser system. It emits laser energy at 755nm and 1064nm wavelengths. It also incorporates a pulsed light XPL handpiece.
Laser activation is by footswitch.
Electrical requirement is 230 VAC, 30A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure Elite MPX Laser System with XPL Handpiece. It states that the device is substantially equivalent to predicate devices based on having the "same indications for use, the same principle of operation, and same parameters."
Crucially, the document explicitly states "Nonclinical none Performance Data:" and "Clinical Performance none Data:" meaning no specific performance data or studies were submitted to establish acceptance criteria or prove that the device meets them.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, or study details because this information is not present in the provided text. The device's clearance was based on its substantial equivalence to previously cleared devices rather than new performance data.
§ 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.