Safety Information

Introduction

  1. Indications For Use
  2. Contraindications for Treatment
  3. Precautions
  4. Potential Adverse Events

1.1. Indications For Use

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.

1.2. Contraindications for Treatment

Treatment with the SofWave System is contraindicated for patients with any of the following
conditions:

  • Open wounds or lesions within the intended treat area.
  • Severe or cystic acne within the intended to treat area.
  • Pacemakers and electronic device implants in treated area.

1.3. Precautions

  • Pregnant or planning to become pregnant, having given birth less than three months
    ago, and/or breast feeding.
  • Presence of any active systemic or local infections.
  • Presence of active local skin disease that may alter wound healing.
  • History of chronic drug or alcohol abuse.
  • Significant scarring in the area to be treated.
  • Presence of a metal stent or implant in the facial area.
  • The SofWave system has not been evaluated for use over various materials.
  • Treatment is not recommended for use directly over areas with a dermal filler.
  • Taking Isotretinoin or other retinoid within the past 6 months; taking psychiatric drugs,
    anti-platelet or anti-coagulant within the past 2 weeks.
  • As per the physician’s discretion, any physical or mental condition which might make it
    unsafe for the patient to be treated.

 

1.4. Potential Adverse Events

Anticipated adverse events of ultrasound-based treatment could include significant pain,
tenderness, changes in skin pigmentation, persistent erythema and edema, ulceration/erosion
and/or bruising.

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