Inspections, Compliance, Enforcement, and Criminal Investigations
Revecomed International Inc 3/1/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
March 1, 2013
Hong B. Kim
Owner and Chief Executive Officer
RevecoMED International, Inc.
2491 E. Orangethorpe Ave.
Fullerton, California 92831
Dear Mr. Kim:
During an inspection of your firm located in Fullerton, California on August 23 through September 5, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the LipoTRON 3000 (also known as RFLipo System, Model DETCBF140). FDA also reviewed your website, http://www.stouchdesign.com/end/revecomed/LipoTron3000.asp, on February 15, 2013. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the LipoTRON 30000 is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body.
During the inspection, FDA learned that your firm claims that it is marketing the LipoTRON 3000 as a therapeutic massager. A therapeutic massager is identified by 21 CFR 890.5660 as "an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains." Therapeutic massagers are Class I and exempt from premarket notification requirements subject to the limitations in 21 CFR 890.9. See 21 CFR 890.5660. Devices of this generic type work by delivering vibration and contain moving components on them that deliver massage, or knead the tissue. However, according to the LipoTRON 3000 User Reference Manual, the LipoTRON 3000 delivers heat to the body via radio frequency energy. Because the LipoTRON 3000 employs a different fundamental scientific technology, it exceeds the limitations of exemption described in 21 CFR 890.9 and is not exempt from premarket notification.
In addition, your website, http://www.stouchdesign.com/end/revecomed/LipoTron3000.asp, includes the following claims about your device:
• ... provides all the advantages of a deep thermal increase to remove subcutaneous fat (cellulite), visceral fat at the same time.
• Lipotron-3000 is a revolutionary Radio Frequency Assisted Lipoplasty (RFAL) System to offer a noninvasive procedure substituting traditional lipo-suction. This procedure has no downtime, side effect, fatigue and maintenance.
The website also includes "before" and "after" photographs showing fat reduction along with the following chart:
|Abdomen Circumference (inch)||43.2||40.5||2.7|
Because the LipoTRON 3000 exceeds the limitations of exemption described in 21 CFR 890.9 and there is no premarket clearance or approval for the device, the LipoTRON 3000 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your film does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
In addition, we note that your firm was aware of and approved marketing materials used by your distributor, Advanced Aesthetic Concepts, LLC (AAC) that included the following indications for use of your device:
• Increase Blood Profusion
• Washing out of tissue exudates
• Increased cell membrane permeability
• Increased tissue elasticity
• Increased tissue oxygenation
• Accelerated macrophage and granulocyte activity
• Increased ATP
These materials market the Lipo-Ex program, which includes your device as a component. In addition to the claims specific to your device, these materials make claims about the Lipo-Ex system, including fat reduction claims, comparisons of Lipo-Ex to surgical procedures, and several "before" and "after" photographs showing weight loss.
Approval or clearance is required before the device may be marketed for the above-referenced indications for use.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly connect these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic connective actions) that your firm has taken. If your firm's planned connections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or connective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to: Blake Bevill, Director, Compliance Branch, Los Angeles District Office, Food and Drug Administration, 19701 Fairchild, Irvine, California 92612. Refer to the Unique Identification Number (CMS case # 367738) when replying. If you have any questions about the contents of this letter, please contact: Jessica Mu, Compliance Officer at (949) 608-4477 or fax: (949) 608-4417.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to connect the violations and bring the product into compliance.
Alonza E. Cruse, Director
Los Angeles District
Cc: Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413