RESONIC™ Important Safety Information

RESONIC™ Important Safety Information

IMPORTANT SAFETY INFORMATION

RESONIC Uses

RESONIC™ (Rapid Acoustic Pulse device) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. RESONIC is also indicated for short-term improvement in the appearance of cellulite. The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness.

General Side Effects and Contraindications

  • The most common side effects may include mild to moderate temporary redness of the treatment site, mild pain, heat, and pinpoint redness.

  • RESONIC is not for everyone, including those who are pregnant or planning to become pregnant during their treatment course.

  • RESONIC should not be used over areas with metal or plastic implants/devices, such as vascular stents or hip or knee implants, or placed over an active skin disorder, including but not limited to rashes, extensive scarring, and psoriasis.

  • Tell your doctor about your medical history, including whether you have any active electronic implants, such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, or drug pumps, as RESONIC should not be used if you are currently using one of those medical devices.

  • You have a medical disorder that would delay the wound healing or immune response, such as blood disorder, diabetes, inflammatory disease, etc.

  • Let your doctor know if you have had a surgical procedure within the last 3 months.

  • Your results and experience may vary, so it is important to talk to your healthcare provider about whether RESONIC is right for you.

 

Cellulite-Specific Side Effects & Contraindications

  • RESONIC is not recommended if you are a current smoker, or if you have a tattoo or former tattoo at or near the treatment area.

Tattoo-Specific Side Effects & Contraindications

  • Other side effects may occur that are related to the laser treatment.

  • RESONIC is not recommended if you have undergone prior tattoo removal on the tattoo you want treated. If you have an amateur, self-applied, or layered tattoo, be sure to get approval from your healthcare provider before treating.

  • Moderate to heavy tanning on and around the tattoo to be treated should be evaluated and approved for treatment by your healthcare provider.