Ultrawave II EX 1320

Nd:YAG 1064nm

Intended for general surgical applications; dermatology/plastic surgery;

endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis;

neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and

orthopedics.

General Surgical Applications:

Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in

dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology,

general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery,

oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology.

Dermatology/Plastic Surgery:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port

wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider

veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as

warts, scars, striae and psoriasis. It addition, the laser is 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 blue and/or black

tattoos), and plaques.

The ULTRAWAVE II EX 1320 laser is also 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 ULTRAWAVE H1 EX 1320 laser is also indicated for the treatment of facial wrinkles

and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The ULTRA4WAVE H EX 1320 is 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 of pseudofolliculitis barbae (PFB).

The ULTRAWAVE II EX 1320 is indicated for the reduction of red pigmentation in

hypertrophic and keloid scars where vascularity is an integral part of the scar.

The ULTRAWAVE II EX 1320 is indicated for use on all skin types (Fitzpatrick I-VI)

including tanned skin, and the removal and permanent reduction of unwanted hair in

Fitzpatrick I-VI, including suntanned skin types.

Orthopedics:

Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and

arthroscopic applications.

Pulmonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obtructions, including

squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and

benign strictures.

Thoracic Surgery:

Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications,

including but not limited to, isolation of vessels for endarterectomy and/or by-pass

grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization,

coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

Urology:

All applications including superficial urinary bladder tumors, invasive bladder

carcinoma, urethral strictures and lesions of the external genitalia (including condyloma

acuminate).

Nd:YAG 1320nm

Indicated for use in general surgery and dermatology for the incision, excision, ablation,

vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the

treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment

of back acne and atrophic acne scars.

Alexandrite 755nm

Intended for coagulation and hemostatis of vascular lesions and the removal and

permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including

suntanned skin types. Also indicated for pigmented lesions and wrinkles.

/PL

590-1200nm: 625-1200nm; 650-1200nm

Indicated for permanent hair reduction.

550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia),

photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of

benign pigmented lesions.

400-1200nm

Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the ULTRAWAVE II EX 1320

hand piece 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 fluencies for laser treatments such

as hair removal and vascular lesion, and to reduce

the potential side effects of laser treatments.

Any other different use is considered incoimect.