Indications for Use
The Sofwave System is indicated for use as a non-invasive, dermatological aesthetic treatment to improve facial lines and wrinkles.
Contraindications for Treatment
Treatment with the Sofwave system is contraindicated for patients with any of the following conditions:
- Open wounds or lesions on the face and/or neck.
- Severe or cystic acne on the face and/or neck
- Pacemakers and electronic device implants in the treated area.
- Pregnant or planning to become pregnant, having given birth less than three months ago, and/or breastfeeding.
- 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.
- Injectable fillers of any type within two weeks; Botox within the past week.
- Taking Isotretinoin or other retinoids within the past two weeks; taking psychiatric drugs, anti-platelet or anti-coagulants within the past two weeks.
- As per the physician’s discretion, any physical or mental condition which might make it unsafe for the patient.
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 a 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.
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