Cynosure Elite MPX

K090235 (Cynosure, Inc., 2009)

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, venous 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, verrucae, 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.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.