MDK Multi-Applications Platform

The MDK Multi-Applications Platform is intended for use in aesthetic, cosmetic and surgical application requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oral surgery as follows:

Nd:YAG 1064nm Q-switched and 532nm Q-switched

The MDK Multi-Applications Platform is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue.

(ablation, vaporization, incision, excision and coagulation of soft tissue) indicated for treatment such as, but not limited to treatment of:

Tattoo removal

1064nm: suggested for dark blue and black ink

532nm: suggested for red, orange, yellow, and purple ink

Pigmented lesion removal (benign)

Cafe au lait spot

Ephelides, solar lentigo (lentigines)

Becker Nevus

retNevus

Nevus spilus

Nd:YAG 1064nm (long & short Pulse)

The MDK Multi-Applications Platform is intended for general surgical applications; dermatology/plastic surgery; endoscopic-laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery and orthopedics; 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, oculoplastic, 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, venous lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. In addition, the laser is intended for the treatment of benign pigmented lesions such as, but not limited to, vitiligo (white 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 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 laser is also indicated for the treatment of facial wrinkles.

It 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). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

It 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.

Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Nd:YAG 1064nm (long & short Pulse) - Continued

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 graft, wedge resections, thoracotomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).

Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis 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 755 nm

Intended for coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

For the coagulation and hemostasis of vascular lesions,

Plastic Surgery

For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins] benign pigmented lesions (nevi, lentigines, chloasma, cafe au-lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

General Surgery:

Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.

Gastroenterology:

Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions), gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).

Head and Otorhinolaryngology (ENT):

Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis during Surgery:

Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.

Neurosurgery:

Hemostasis for: Pituitary Tumor, Meningioma; hemangioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.

Ophthalmology:

Post-vitrectomy endophotocoagulation of the retina.

Nd:YAG 632nm (long pulse) - continued

Pulmonary Surgery

Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma; carcinoid; benign tumors; granulomas; benign strictures.

Thoracic Surgery

Cutting (incision and ablation), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: isolation of vessels for endarterectomy and/or by-pass graft, wedge resections, thoracotomy, formation of pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation of lung tissue (thoracoscopy).

All applications including: superficial urinary bladder tumors, invasive bladder carcinoma; urethral strictures; lesions of the external genitalia (including condyloma acuminata).

IPL 590-1200nm; 626-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

IPL 560-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (beam of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the MDK Multi-Applications Platform 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 treatment.

Any other different use is considered incorrect.