Alma Q

The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.

a) LP1064nm
1. 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.
2. The Alma Q laser system is also indicated for the treatment of wrinkles.
3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
4. The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
5. The intended use of the integral cooling system in the Alma Q laser 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.

b) QS 532nm
1. Tattoo removal
   - Red inks
   - Blue and light blue inks
   - Green inks
2. Treatment of vascular lesions
   - Telangiectasias
   - Spider angiomas
   - Cherry angiomas
   - Spider nevi
3. Treatment of pigmented lesions
   - Cafe-au-lait birthmarks
   - Volar lentigines
   - Solar lentigines
   - Becker's nevi
   - Freckles
   - Nevus spilus
   - Nevus of ota
4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology.

c) QS 1064nm
The Alma Q laser treatment system is intended for use:
1. For the removal or lightening of unwanted facial or body hair.
2. For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery.
3. For the treatment of dermal pigmented lesions (dermal melanocytosis); and
4. For tattoo removal (dark and blue inks).

The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery. It is indicated for the coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins, and spider veins. The Alma Q laser system is also indicated for the treatment of wrinkles, the removal of unwanted hair, and for the treatment of pseudofolliculitis barbae (PFB). The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin. The intended use of the integral cooling system in the Alma Q laser 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.

The subject device, Alma Q Laser, incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices, and medical spas. The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.