INDICATION

• The radiofrequency energy only delivery components of the Thermage 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 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 undergo a Thermage treatment if you have a cardiac pacemaker or other active implants. Inform your doctor if you have this condition or are in doubt.

• The most common adverse effects include:
  • Surface Irregularities: Frequently, surface irregularities are not evident immediately post-treatment, but may appear up to 1 or more months post-treatment.
  • Altered Sensation: Numbness, tingling, or temporary paralysis that typically resolves in a short period of time, but may persist up to several weeks.
  • Burns, Blisters, Scabbing, and Scarring: The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation.
  • Lumps / Nodules: lumps or nodules under the skin may occur primarily in the neck area that usually resolve within 1 or 2 weeks without chronic or long term complications.
  • Pigment Changes: Hyperpigmentation (darkening of the skin) that normally resolves within several months.
  • Edema: Swelling may occur and typically resolves within 5 days, but can persist up to several weeks.
  • Mild to Moderate Pain: Typically, the discomfort is temporary during the procedure and localized within the treatment area.

INDICATION

The Clear + Brilliant^® system is a non-ablative laser for general skin resurfacing, which can help improve skin tone, texture, fine lines, and overall appearance of the skin, and reduce the appearance of pore size.

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. You may not be an appropriate candidate for a treatment if you:
  • Have been diagnosed with or possibly have actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g., skin cancer, active infections, cold sores, open wounds or a sore that has not or will not heal, rashes, burns, inflammation, eczema, psoriasis);
  • Are predisposed to keloid formation or excessive scarring;
  • Have a condition that may compromise the immune system, or your ability to fight infections, such as HIV, lupus, scleroderma, or infections in the blood stream;
  • Have a known sensitivity to light or if you are taking any medications that may make your skin more sensitive to UV or artificial light;
  • Are on oral/systemic steroids (e.g., prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment;
  • Are using retinoids, which should be avoided for at least 2 weeks prior to and during treatment;
  • Are undergoing isotretinoin acne treatment or taking drugs in a similar class;
  • Have skin that is still recovering from a cosmetic procedure, such as a chemical or mechanical peel, or laser resurfacing; and
  • Have had botulinum toxin injections, or dermal fillers (such as collagen or hyaluronic acid) 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 skin resurfacing procedures, including the treatment of dyschromia (an alteration in the color of the skin) and for local inflamed, benign skin lesions, such as, but not limited to, lentigos (small, pigmented, benign spots), sun spots, actinic keratosis (pre-cancerous skin lesions), and melasma; and for the treatment of wrinkles around the eyes, acne scars, and surgical scars.
• Fraxel^® 1927nm wavelength is indicated for skin resurfacing including for the treatment of actinic keratosis (pre-cancerous skin lesions); treatment of pigmented lesions, such as age spots, sun spots, and freckles.

IMPORTANT SAFETY INFORMATION

• The following contraindications are routine for many laser treatments and may also be associated with non-ablative Fraxel^® laser systems treatments. You may not be an appropriate candidate for a Fraxel^® treatment if you:
  • Are predisposed to keloid formation or excessive scarring;
  • Have experienced pigmentation changes of the skin following surgery;
  • Have had skin indentations and textural changes following surgery;
  • Are on systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; and
  • Are undergoing isotretinoin acne treatment or are taking drugs in a similar class.
• Possible Complications from Fraxel^® treatment include:
  • Blistering and Burns: May develop over the treated areas.
  • Discoloration: The possibility of temporary and permanent skin color change is known to exist with any laser treatment and may occur.
  • Eye Injury: The Fraxel^® DUAL generates an intense beam of laser radiation which may cause injury if not used properly. Protective eyewear or goggles should be worn. It is important to keep the eye protection on at all times during treatment in order to protect your eyes from accidental laser exposure and serious injury.
  • Infection: A risk of infection exists whenever the skin is wounded. The possibility for infection exists even with non-ablative fractional laser devices such the Fraxel^®.
  • Keloid Formation: A thickened scar can result from excessive growth of fibrous tissue.
  • Prolonged Redness: Mild to moderate transient redness is an expected response. However, if it is severe or persists significantly longer than expected, you should not have another treatment until it goes away.
  • Scarring: The possibility for scarring exists. Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.
  • Delayed Wound Healing / Skin Textural Changes: Following laser treatment, restoration of the skin may not occur as expected due to your physiology, such as poor wound healing ability or post-treatment care. This may result in undesirable textural changes to the skin.
  • Temporary Bruising: May develop over the treated areas.

INDICATION

VASERlipo is used to remove fatty tissue for aesthetic body contouring. VASERlipo is also used in the following surgical specialties for the removal 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 undergo VASERlipo treatment if you have 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. Inform your doctor if you have any of these conditions or are in doubt.
• 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.