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 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.
• 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.

Talk to your doctor for more information about Thermage.