INDICATION

• The radiofrequency energy only delivery components of the Thermage FLX^® system and accessories are indicated for use in:
  • Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
  • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; and
  • Non-invasive treatment of wrinkles and rhytids.
• The simultaneous application of radiofrequency energy and skin vibration by the Thermage FLX^® system and accessories are indicated for use in:
  • Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
  • Non-invasive treatment of periorbital wrinkles and rhytids;
  • Non-invasive treatment of wrinkles and rhytids;
  • Temporary improvement in the appearance of cellulite;
  • Relief of minor muscle aches and pains;
  • Relief of muscle spasms; and
  • Temporary improvement of local circulation (blood circulation).

IMPORTANT SAFETY INFORMATION

• Do not use the Thermage FLX System in patients with cardiac pacemakers or other active implants.

INDICATION

Clear + Brilliant^® laser system (1440nm and 1927nm handpieces) is indicated for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing.

IMPORTANT SAFETY INFORMATION

• The following contraindications are routine for many laser treatments and may also be associated with non-ablative Clear + Brilliant laser system treatments. Pre-screening should include, but not be limited to:
  • Diagnosis / possibility of actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g., skin cancer, active infections, cold sores, open wounds, rashes, burns, inflammation, eczema, psoriasis);
  • Predisposition to keloid formation or excessive scarring;
  • Diagnosis of a condition that may compromise the immune system, such as HIV, lupus, scleroderma, or systemic infections;
  • Known sensitivity to light or if photosensitizing agents or medications are being taken;
  • Systemic steroids (e.g., prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment;
  • Use of retinoids, which should be avoided for at least 2 weeks prior to and during treatment;
  • Patients undergoing isotretinoin acne treatment or with drugs in a similar class;
  • Whether skin is still recovering from a cosmetic procedure, such as a chemical or mechanical peel, or laser resurfacing; and
  • Whether botulinum toxin injections, or dermal fillers (such as collagen) have occurred within the past 2 weeks.

INDICATION

The Fraxel^® 1550, Fraxel^® 1927, and Fraxel^® DUAL 1550/1927 laser systems are cleared for the following indications for use:

• Fraxel 1550nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; skin resurfacing procedures; treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos, solar lentigos, actinic keratosis, and melasma; and treatment of periorbital wrinkles, acne scars, and surgical scars.
• Fraxel 1927nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; treatment of actinic keratosis; treatment of pigmented lesions, specifically age spots, sun spots, and ephiledes.

IMPORTANT SAFETY INFORMATION

• The following is a summary of contraindications for Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 laser systems treatments. Pre-screening should include, but not be limited to:
  • Predisposition to keloid formation or excessive scarring;
  • Pigmentation changes following surgery;
  • Skin indentations and textural changes following surgery;
  • Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; and
  • Patients undergoing isotretinoin acne treatment or with drugs in a similar class.
• Do not use Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927on any patient who is ineligible for general surgery.
• The Fraxel 1550, Fraxel 1927 and Fraxel 1550/1927 DUAL generate a Class 4 laser. Protective eyewear or goggles should be worn by any operator and assistant.

INDICATION

VASERlipo^® system is indicated for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring. VASERlipo is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues:

• Neurosurgery;
• Gastrointestinal and Affiliated Organ Surgery;
• Urologic Surgery;
• Plastic and Reconstructive Surgery;
• General Surgery;
• Orthopedic Surgery;
• Gynecologic Surgery;
• Thoracic Surgery; and
• Laparoscopic Surgery.

IMPORTANT SAFETY INFORMATION

• Do not use VASERlipo in patients with chronic medical conditions, such as obesity, diabetes, blood clotting disorders, heart, lung, or circulatory system disease, or vascular problems, including common circulation problems and coagulation problems associated with certain medications.
• The following conditions may also affect the safety or effectiveness of VASERlipo:
  • Presence of collagen, scarring, or connective tissue disorders;
  • Presence of stretch marks of potential for stretch mark formation;
  • Lupus Erythematosus;
  • Endocrine disorders; and
  • Pregnancy, or the possibility of pregnancy.

INDICATION

The Isolaz 2 system is indicated to treat mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

IMPORTANT SAFETY INFORMATION

• Do not undergo Isolaz treatment if any of the following conditions apply to you:
  • You have cancer, including malignant melanoma or recurrent non-melanoma skin cancer, or pre-cancerous lesions or other suspicious lesions in the treatment area;
  • You are predisposed to keloid formation, excessive scarring, or poor wound healing; or
• You have used isotretinoin within the past 6 months.

INDICATION

The Clear + Brilliant pélo^® laser (GME LinScan System 808) with applicators is indicated for hair removal and permanent hair reduction at 6, 9, or 12 months following a treatment regime.

IMPORTANT SAFETY INFORMATION

• You should not have Clear + Brilliant pélo laser treatments if you:
  • Experience long healing periods after preceding Clear + Brilliant pélo laser treatments
  • Have tanned skin
  • Are susceptible to keloid (enlarged scar) or abnormal scar formation
  • Are susceptible to lightening or darkening of the skin
  • Are undergoing Isotretinoin treatment or are taking drugs in a similar class
  • Are undergoing treatment with medications that cause the skin to be very sensitive to sunlight, such as tetracyclines or retinoids
  • Use hydroquinone or other skin bleaching agents
  • Have known herpes infection, cold sores, or genital warts in treatment area
  • Have a tattoo in the treatment area
  • Are pregnant
  • Have used other hair removal devices or other hair removal methods, e.g., waxing, hair plucking, or hair removal by electrolysis during the preceding 6 weeks.
• You should consult your doctor regarding treatment for herpes (cold sores or genital warts) prior to pélo treatment if you have a previous history of herpes infection(s).
• The Clear + Brilliant pélo laser is a class IV laser; i.e., it may cause damage to the eyes and skin.
• You must therefore wear protective eyewear or goggles during your Clear + Brilliant pélo laser treatment.
• Possible Complications from Clear + Brilliant pélo laser treatment include:
  • Temporary redness of the skin, similar to sunburn
  • Blister formation over the treated areas
  • Swelling caused by fluid retention
  • Skin discoloration:
    • Pigmented lesions and freckles may bleach or disappear
    • Darkening of skin
    • Loss or lightening of skin color
    • Red spots on skin
  • Light pain
  • Scarring
  • Activation of herpes simplex (cold sores or genital warts) in patients already infected
  • Increased sweating
  • Strong smell and excessive sweating
  • White hair

INDICATION

The Liposonix^® system is indicated for non-invasive waist circumference reduction.

IMPORTANT SAFETY INFORMATION

Contraindications (When you should NOT have Liposonix treatment):

You should not have the Liposonix^® treatment if you are pregnant, think you may be pregnant, or if you are breastfeeding (lactating). You must have at least a centimeter of fat (about half an inch) more than the depth setting of the system in the area to be treated in order to avoid injury. You cannot have a hernia in the area to be treated in order to avoid injury.

Warnings (When Liposonix treatment may result in injury or may not be successful):

Tell your doctor if you think you might have any of these conditions: skin folds or poor skin flexibility in the areas to be treated, skin in the areas to be treated that does not lie flat or folds during treatment, any skin disease or open sores in the areas to be treated, swollen, infected, or irritated areas, implants or foreign bodies of any type that cannot be removed in the areas to be treated, are taking blood thinners or other medications which may increase the risk of bleeding, are on long-term therapy that reduces your resistance to disease, have had any prior treatment or surgery in the area planned for treatment, have a loss of feeling in the areas to be treated, have a disease that affects your whole body, a disease that has lasted a long time, or have wounds or some types of scars in the areas to be treated.