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1. Reported in New Beauty Media Kit
2. Suneva Medical Consumer Attitudinal Post COVID-19 Study. June 2020. n=499
IMPORTANT SAFETY INFORMATION
Bellafill is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. Patients who have had a positive reaction to the Bellafill Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill. The safety of Bellafill for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/ papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by your licensed physician provider. Be sure to call your licensed provider immediately if you notice any unusual skin reactions around the treatment area. Based on the 5-year Post-Approval Study on nasolabial folds with 1,008 patients, long-term safety of Bellafill for up to 5 years has been established. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.bellafill.com.
Silhouette lnstaLift is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub-dermis in an elevated position. The Silhouette InstaLift device should not be used in patients with any known allergy or foreign body sensitivities to plastic/ biomaterial or in situations where internal fixation is otherwise contraindicated, (e.g. infection.) The device should also not be used in patients appearing to have very thin soft tissue of the face in which the implant may be visible or palpable. Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include but are not limited to infection, minimal acute inflammatory tissue reaction, pain (which may be temporary or persistent in nature), swelling and edema, transient hematoma or bruising and transient rippling or dimple formation. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.instalift.com.
PLASMA IQ is FDA cleared to be used in the removal and destruction of skin lesions and the coagulation of tissue. The most common side effects are swelling, tenderness, scabbing and redness. PLASMA IQ is Rx only and should only be used by medically licensed and certified practitioners. For full product and safety information, visit https://www.sunevamedical.com/ifu/
Suneva Medical HD PRP
FDA-cleared 510(k) Class II medical device. Healeon HD PRP is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of peripheral blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. 510(k) number: BK170136. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.sunevamedical.com.
Dermapose Refresh is a sterile medical device intended for the processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. Dermapose Refresh is contraindicated for use in intravenous applications. Fat tissue harvested with Dermapose Refresh is only to be used for reimplantation without any additional manipulation. Extreme caution should be taken when using Dermapose Refresh in patients with chronic medical conditions, such as diabetes, heart or lung diseases, circulatory disease, or obesity. Results of the procedure may or may not be permanent. Results of the procedure will depend upon patient age, surgical sites, and experience of the surgeon. Fat removal should be limited to that necessary to achieve a desired cosmetic effect. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.dermapose.com.
This product is certified as a medical device in the European Union under the Medical Device Directive 93/42/EEC by SGS CE0120, exclusively for the indication of autologous fat transfer. Other non-medical uses ascribed to this device such as aesthetic body contouring are not within the scope of CE certification, and users should be aware product performance and/or safety has not been evaluated by SGS for those purposes. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.puregraft.com.
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