Important Safety Information

Indication

The Thermage^® System is indicated for use in dermatologic and general surgical procedures to address skin laxity, including:

• Non-invasive treatment of wrinkles and rhytids;
• Non-invasive treatment of wrinkles and rhytids around the eyes, including upper and lower eyelids; and
• Temporary improvement in the appearance of cellulite.

Important Safety Information

• Do not undergo 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.