Terms of Use

By accessing, viewing, or otherwise using this Website, you agreeing to the following disclaimers and notices (“disclaimers and notices”). “You”, “your” and “user” refer to all individuals and/or entities accessing this Website for any reason. “We”, “us”, and “our” refer to the Website owner(s) and/or operator(s). Please read these disclaimers and notices carefully:

Changes to Disclaimers and Notices

Your access to and use of this Website and all content (“Website Content”) are subject to these Disclaimers and Notices, and applicable laws and regulations (including all export and import laws, regulations and restrictions), all of which are subject to change from time to time without prior notice. From time to time, we may: (a) supplement or make changes to these Disclaimers and Notices and other rules or access and use procedures, documentation, security procedures and standards for equipment; (b) change the type and location of Website Content, system equipment, facilities or software; or (c) modify or withdraw any particular service or product referred to in this Website or any Website Content. We reserve the right to terminate access to this Website or take other actions we reasonably believe necessary to comply with the law or to protect our rights, affiliates or customers. Any access or attempt to access or use this Website for any unauthorized or illegal purpose is strictly prohibited.

No Guarantee

We make no guarantee as to, and assume no responsibility for, the correctness, sufficiency or completeness of any Website Content or recommendations on this Website. We do not represent or endorse the accuracy or reliability of any Website Content or advertisements, or information contained on, distributed through, or linked, downloaded or accessed from this Website, nor the quality of any Website Content displayed, obtained or purchased by you as a result of your use of this Website or any Website Content. You hereby acknowledge that any reliance upon this Website, any Website Content or any third-party content shall be at your sole risk. We reserve the right, in our sole discretion and without any obligation, to correct any error or omissions in any portion of this Website or any Website Content at any time, with or without notice to you.

Restrictions on Use

Without our prior written consent, which consent may be given or withheld in our sole discretion, you may not: (a) sell, resell, sublicense, rent, lease, display, disseminate or otherwise publicly distribute any Website Content, or any part or parts thereof or information contained therein, or any access thereto; (b) use your access to this Website or any Website Content to export or re-export technical data in violation of U.S. export control laws and regulations; (c) use this Website or any Website Content which you access in violation of, or post any information to any of our owned or licensed database which violates, any federal or state law, including data privacy laws and communication regulations and tariffs, or which infringes the intellectual property rights or misuses proprietary information of a third party or is made in furtherance of an illegal or fraudulent scheme or activity; (d) copy or transfer any Website Content; or (e) modify, adapt, reverse engineer, decompile, disassemble, translate or convert any portion of this Website or Website Content, or the selection, coordination or arrangement of the Website Content.

Submissions and Ideas

Any information, including but not limited to remarks, suggestions, ideas, graphics or other submissions, communicated to us through this Website is deemed non-confidential and is our exclusive property. We are entitled to use any information or ideas submitted for any purpose without restriction and without compensation to or attribution or acknowledgement of the source.

Trademarks and Notices

Except as otherwise identified, the trademarks, including names, logos, slogans and service marks appearing at this Website, and copyrights, whether registered or unregistered, are our property. Such trademarks and copyrights are not to be copied, reproduced, published or in any way used without written permission. No part of this Website may be published, stored or transmitted in any form or means without our express written permission. You may download Website Content displayed on this Website for non-commercial, personal use only and must retain all copyright and other proprietary notices contained in the Website Content.

Hyperlinks

You may not establish Hyperlinks either to this Website or away from this Website without our prior written consent, which consent may be given or withheld in our sole discretion. In our sole discretion, we reserve the right to remove a Hyperlink to this Website or away from this Website at any time and for any reason. Contact us at info@sunevamedical.com to request this consent. All Hyperlinks approved shall be to the home page of this Website. Framing at this Website is expressly prohibited.

Third Party Sites

We advise you to exercise discretion while browsing this Website and the Internet. In addition, Hyperlinks on this Website may direct you to sites containing information that some people may find offensive or inappropriate. Such linked Websites may not be under our control, and we do not make any representations or warranties concerning any such Websites which you may access via a Hyperlink from this Website, and accordingly we are not responsible for the accuracy, copyright compliance, legality, legitimacy or decency of material contained in Websites which may be accessible via a Hyperlink to or from this Website or for the Hyperlink itself. We provide these Hyperlinks to you only as a convenience, and the inclusion of any Hyperlink on this Website is not and should not imply any endorsement by us of such linked Websites.

Disclaimer of Warranties

All information and/or Website content on or obtained through this Website are provided “as is” and without warranty of any kind, and you hereby waive all other warranties relating thereto, including but not limited to any warranty of merchantability, fitness for a particular purpose, custom, usage, or warranty against interference or infringement. We do not warrant that any Website content or other information will meet your requirements, that the operation of any Website content, other information or any third-party Website content used with or through or provided by us or any part thereof, will be uninterrupted or error free or that any defects in such information or Website content will be or can be corrected. In no event shall we have any liability to you (including liability to any person or person’s claims are based on or derived from a right or rights claimed by you) with respect to any and all claims at any and all times arising from or related to the subject matter of this Website or the Website content, in contract, tort, strict liability, or otherwise. Some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you.

Security

You assume the responsibility to take adequate precautions against damage to your systems or operations which could be caused by defects or deficiencies in this Website or any Website content. You also acknowledge that electronic communications and databases are subject to errors, tampering and break-ins and that while we will implement reasonable security precautions to attempt to prevent such occurrences, we do not guarantee such events will not take place. Your installation and input, as well as third-party systems and procedures, may influence the output and errors in any order electronic transmission or communication, and can result in substantial errors that output, including incorrect information, orders and transactions. In addition, errors may be introduced into information or orders in the course of their transmission over electric networks. You shall implement and take responsibility for appropriate review and confirmation procedures to verify and confirm orders or other transactions in which you participate using this Website or any Website content.

Indemnification

You also are solely responsible for ensuring that any posting made by or for you to this Website does not contain any virus or other computer software code or routine designed to disable, erase, impair or otherwise damage the Website or any software, hardware, information, data, system or content of any other user of the Website or Website content. You hereby agree to indemnify, defend and hold us and our employees, agents, representatives,  licensors, and suppliers harmless from any liability, claim, cost, or damage, arising out of any claim or suit by any such user caused by such virus or code or subroutine.

Limitation of Liability

We shall not in any event be liable to you or any third party for any direct, indirect, special, consequential, or incidental losses, damages or expenses including for any lost profits, revenues, business opportunities or business advantages whatsoever directly or indirectly relating to the use or misuse of this Website, the Website content or with respect to any other hyperlinked Website, or any other material or software used therewith, the use or failure non-compliance or limited availability of any Website content provided by us through the Website, any information provided in the company system or any obligation under or subject matter of this Website, whether such claim is based upon breach of contract, breach of warranty, negligence, gross negligence, strict liability in tort or any other theory of relief, or whether or not we are informed in advance of the possibility of such damages.

General

If any part or parts of these Disclaimers and Notices are held to be invalid, the remaining parts will continue to be valid and enforceable. Nothing in these Disclaimers and Notices affects any statutory rights of consumers that cannot be waived or limited by contract. The use by you of this Website, the Website Content, and any and all other matters related hereto, shall be governed by applicable United States federal law and the laws of the State of Illinois, excluding its conflict-of-laws rules. You hereby agree to waive any right to a jury trial in any suit arising out of or relating to this Website or any Website Content. Any suit or proceeding arising out of or relating hereto must be commenced within one year from the date the right, claim, demand or cause of action being asserted first came into being. Venue for all disputes arising out of or relating to this Agreement shall be in the state and federal courts situated in Chicago, Illinois.

Export Laws; Third Party Products and Services

You agree to comply with all applicable export laws, regulations and restrictions. Website Content we place on or make available through this Website may contain references or cross references to third party products, programs and services that are not announced or available in your country. Such references do not imply that either we or such third party intends to announce or make available such products, programs or services in your country. Consult us or the applicable third party for information regarding any such products, programs or services. This Website may contain other proprietary notices and copyright information, the terms of which must be observed and followed. Any rights not expressly granted herein are reserved.

Proper Notice

Communications made by e-mail or though this Website shall in no way be deemed to constitute legal notice to us or any of our divisions, subsidiaries, affiliates, officers, employees, agents or representatives regarding any existing or potential claim, or cause of action against us or any of our divisions, subsidiaries, affiliated companies, officers, employees, agents, or representatives, where notice is required by any federal, state or local laws, rules or regulations.

Terminology

The information and Website Content may use terms that have technical meanings that may be different from their ordinary meanings and require specialist knowledge and expertise to understand properly and use effectively.

Questions

If you have any questions regarding this Website, the Website Content, or these Disclaimers and Notices, contact us at info@sunevamedical.com.

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

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.