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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.

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