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BIOSTIMULATOR

THE ONLY FDA APPROVED 5-YEAR FILLER THAT STIMULATES PATIENT’S OWN NATURAL COLLAGEN.

RESORBABLE
SUTURE

THE FIRST ABSORBABLE SUTURE THATS’S FDA CLEARED FOR COSMETIC FACIAL PROCEDURES.

THE FIRST FDA CLASS II CLEARED PLASMA ENERGY DEVICE

PLASMA ENERGY
DEVICE

COMPREHENSIVE SKIN REJUVENATION

MICRO-INFUSION
SYSTEM

COMPREHENSIVE SKIN REJUVENATION

PLATELET
RICH PLASMA

A PLATFORM TO PROCESS AND CAPTURE OPTIMAL PLATELET CONCENTRATES.

FAT GRAFTING

THE MOST PREDICTABLE FAT GRAFT ON THE MARKET.

Optimal Fat Sizing For Efficacy
INjectability,and Viability

WHAT’S HAPPENING AT SUNEVA MEDICAL

Recent News

Plasma IQ Acquires Health Canada ApprovalFebruary 6, 2021
Suneva Medical and Neauvia North America Enter into a New Strategic PartnershipSeptember 22, 2020
Suneva Medical Increases Its Leadership in Regenerative Aesthetics with New PartnershipMay 1, 2020

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PROVIDER

FOR FURTHER INFORMATION

Please use this form to contact Suneva Medical for:

MEDIA INQUIRIES

For press inquiries, please contact at (646) 599-8602 or IHudanich@rxmedyn.com

MEDICAL AFFAIRS INFORMATION

To request medical information, please complete this electronic form: Medical Information Request

Note: Requests are not valid without practitioner’s e-signature.

PRODUCTS

We strive to ensure a positive experience for patients and practice partners and are continuously committed to providing ongoing support programs and special promotions. Call us at (858) 550-9999.

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.