Thermage^® System Indications and Important Safety Information

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 wrinkles around the eyes, including upper and lower eyelids
  • Non-invasive treatment of wrinkles

• 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 wrinkles around the eye
  • Non-invasive treatment of wrinkles
  • Temporary improvement in the appearance of cellulite
  • Relief of minor muscle aches and pain
  • Relief of muscle spasms
  • Temporary improvement of local circulation (blood circulation)

IMPORTANT SAFETY INFORMATION

• Do not undergo Thermage^® treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator, or any other electrical implant. Let your doctor know if you have an electrical implant or
  if you have any questions about whether you should undergo a Thermage^® treatment.

• Solta Medical has not studied the use of the Thermage^® system:
  • Over skin fillers (lips, cheeks, facial wrinkles and skin folds)
  • In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy
  • In people who have permanent make-up and/or tattoos
  • In children

• The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated.

• The most commonly reported adverse effects after treatment include the following:
  • Mild redness may occur and typically resolves within 24 hours.
  • Swelling may occur and typically resolves within 5 days, but can remain up to several weeks.
  • The following adverse effects occur infrequently:
    • 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.
    • Skin surface irregularities may appear up to 1 or more months post-treatment.
    • Numbness, tingling” or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks.
    • Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications.
    • Skin may darken, but normally resolves within several months.

Talk to your doctor for more information about Thermage.