Cutera CoolGlide CV/Excel

K023954 (Altus Medical, Inc., 2003)

The family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. 1064nm: Dermatology: The Altus Medical Aesthetic CoolGlide laser systems are 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 and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos(significant reduction in the intensity of black and/or bluehlack tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and periorbital wrinkles. The CoolGlide lasers are also 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 for pseudofolliculitis barbae (PFB). The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned slun. The intended use of the integral cooling system in the Altus handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. Optional Pulsed Light Hand Piece: For the treatment of benign pigmented lesions.

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

K132185 (Cutera, Inc., 2013)

Family of CoolGlide Aesthetic Lasers The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 755 nm: The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as tong-term, stable reduction in hair counts observed atS6, 9,and 12 months after the end of a treatment regime. The Family of CoolGlide Aesthetic Lasers is also indicated for: o treatment of benign pigmented lesions o treatment of wrinkles ol photocoagulation of dermatological vascular lesions such as, but not limited to, port wine stains, hemangiomas and telangiectasias 1064 nm: Dermatology: The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rossosa, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as, but not limited to, warts, scars, striae and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age soots), solar lentigos (sun spots), caf4 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. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

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