News & Press

Plasma IQ Acquires Health Canada Approval

February 6, 2021

January 21, 2021 (San Diego, CA) – Suneva® Medical, Inc., a privately held aesthetics company, is pleased to announce the approval of Neauvia North America’s Plasma IQTM by Health Canada, making it the first and only approved hand-held plasma energy device for the aesthetic market. Plasma IQTM is the latest advancement in aesthetics that delivers …

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Suneva Medical and Neauvia North America Enter into a New Strategic Partnership

September 22, 2020

September 21, 2020 (San Diego, CA) – Suneva® Medical, Inc., a privately held aesthetics company, is pleased to announce an exclusive strategic partnership to market and distribute Neauvia North America’s Plasma IQ, the first Class 2 FDA cleared plasma energy device throughout North America.  Plasma IQ is the latest advancement in aesthetics that delivers focused, …

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Suneva Medical Increases Its Leadership in Regenerative Aesthetics with New Partnership

September 22, 2020

April 15, 2020 (San Diego) — Suneva® Medical, Inc., is proud to announce an exciting new partnership that will further its leadership position in regenerative aesthetics.  The exclusive North American distributorship for Sinclair Pharma’s innovative Silhouette Instalift® sutures will expand Suneva Medical’s aesthetic portfolio that addresses the growing market demand for natural and minimally invasive alternatives in aesthetics.  “We …

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Women In Aesthetics: Pat Altavilla

August 30, 2019

With more than 30 years’ experience in the aesthetics and medical fields, Pat Altavilla has emerged as a very familiar face in the aesthetics industry. She began her career at Mentor Corporation and served as Vice President of International Sales and Worldwide Marketing. For nearly two decades, she was instrumental in growing their sales tenfold …

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BRIAN PILCHER, PHD APPOINTED AS CHIEF SCIENTIFIC OFFICER AT SUNEVA MEDICAL

April 17, 2019

March 28, 2019 (San Diego) — Suneva® Medical, Inc., privately held aesthetics company, announces the appointment of Chief Science Officer, Brian Pilcher PhD. Dr. Brian K. Pilcher joins Suneva Medical with over 18 years of experience in Dermatology and Aesthetics, most recently as Principal of Critical MASS Scientific Strategy Consultants, where he worked to develop programs in support of established …

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PATRICIA ALTAVILLA APPOINTED AS CHIEF EXECUTIVE OFFICER AT SUNEVA MEDICAL

April 17, 2019

Company Advances into Next Phase of Regenerative Aesthetics with Industry Veteran March 5, 2019 (San Diego, CA) – Suneva® Medical, Inc., privately held aesthetics company, announces Chief Executive Officer, Patricia Altavilla as successor to Preston Romm. With over 30 years’ experience in the aesthetics and medical fields. Altavilla began her career at Mentor Corporation, serving …

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Important Safety Information

Bellafill®
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.

PUREGRAFT
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.

Suneva Medical HD PRP
REGULATORY STATUS: 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/orallograft bone prior to application to a bony defect for improving handling characteristics. 510(k) number: BK170136

Silhouette Instalift
Silhouette lnstaLift® is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub-dermis in an elevated position.

IMPORTANT SAFETY CONSIDERATIONS
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 further safety or product information, please consult your physician.

For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.bellafill.com.
Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234).
Local calls: 858-550-9999. International calls: ++ 858-550-9999.