- Intended Use / Indications For Use
- Potential Adverse Events
1.1. Intended Use / Indications For Use
The Sofwave system is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.
- Open wounds or lesions on the face and/or neck.
- Severe or cystic acne on the face and/or neck
- Pacemakers and/or electronic device implants in the treated area.
- 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.
- On-going use of psychiatric medication.
- 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 six months; taking psychiatric drugs, anti-platelet or anti-coagulants within the past six months.
- As per the physician’s discretion, any physical or mental condition which might make it unsafe for the patient.
1.4. Potential Adverse Events
Adverse events reported in the clinical evaluation of the Sofwave system were mild and transient in nature. They were limited to:
- Erythema: The treated area may exhibit erythema immediately
following treatment. This typically resolves within
several hours/days of treatment.
- Edema: The treated area may exhibit edema following
treatment. This typically resolves within few several
days of treatment.
- Pain: Moderate discomfort may be experienced during the
treatment. Post procedure discomfort or tenderness
is also possible.
Additional potential adverse events include: changes in skin pigmentation, ulceration/erosion and/or bruising.
No serious adverse events were observed during the clinical study evaluation of the Sofwave system.