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

Contraindications: The Thermage ® [CPT] [FLX] System is contraindicated for use in patients with an implantable pacemaker, an automatic implantable cardioverter / defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency (RF) field or current.

Precautions:

• 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, are diabetic, have an auto-immune disease such as lupus, have cold sores, have herpes simplex, or have epilepsy
• In people with permanent makeup and/or tattoos
• In children

Warnings:

• Treatment of the upper or lower eyelids, or within the orbital rim, requires the use of PLASTIC eye shields, DO NOT use metal shields.
• Do not use vibration when treating the face around the eye areas while plastic eye shields are in use. Vibration may cause displacement of the ocular shields resulting in increased risk of corneal abrasions or ocular damage.

Possible Adverse Patient Reactions:

Reports of adverse patient reactions have included:

• During treatment: mild-to-moderate pain
• After treatment:
• Edema
• Erythema or blanching
• Urticaria
• Bruising
• Blisters, burns, scabbing or scarring
• Surface irregularities
• Altered sensation
• Lumps or nodules
• Pigment change
• Rare cases of herpes simplex virus reactivation in the perioral and genital skin areas

ATTENTION: THIS IS NOT ALL YOU NEED TO KNOW. Improper use of the Thermage® FLX System may cause personal injury, injury to the patient, or damage to the system. See the User’s Manual and other labeling for detailed directions, proper use, and full risk and safety information. For additional product information, please visit www.thermage.com.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.