Advance-Esthetic LLC

During an inspection of your firm located in Fort Lauderdale, Florida from October 27, 2025, through November 6, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Our inspection revealed that the Zemits CrystalFrax Pro, Zemits Abigon Pro and Zemits Bionexis Lite Pro are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm 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) for the device as described and marketed.

The Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro are 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) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Specifically, your firm has listed the Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro devices under product code ISA, classified under 21 CFR 890.5660. Devices classified under 21 CFR 890.5660 Therapeutic Massagers are electrically powered devices intended for medical purposes, such as to relieve minor muscle aches and pains, and are exempt from premarket notification requirements unless they exceed the limitations at 21 CFR 890.9(a)-(b). FDA has reviewed your device listings, information collected during your most recent inspection, and your firm’s website and has determined that none of the subject devices fall within the scope of this classification.

The listed devices exceed the limitations in 21 CFR 890.9(a)-(b) applicable to exempt devices because they use a different fundamental scientific technology (radiofrequency energy and light-based technology) and because they are intended by you for uses that are different from the intended use of legally marketed devices in that generic type of device.

The Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro are all devices that use radiofrequency energy and light-based technology for non-invasive body contouring of skin and cellulite. Radiofrequency (RF) energy works by increasing the temperature of skin by deposition of RF waves to relieve minor aches and pain. Light-based technology works through the interaction of light with the fat tissue. In contrast, electric therapeutic massagers classified under 21 CFR 890.5660 are largely air pressure-based devices that deliver massaging vibrations to the tissue. Because your devices operate using a different fundamental scientific technology than legally marketed devices in the generic type of devices of therapeutic massagers regulated under 21 CFR 890.5660, these devices exceed the limitations described in 21 CFR 890.9(b) and are not exempt from premarket notification requirements.

Additionally, these devices are intended by you for uses that are different from the intended uses of legally marketed devices in this generic type of device classified under 21 CFR 890.5660 as therapeutic massagers. For example, marketing materials for the Zemits Bionexis Lite Pro on your firm's website indicate that the product can be used to "reduce cellulite appearance," "decrease appearance of stretch marks," and "reduce edema and puffiness." Your firm's website further describes the Zemits CrystalFrax Pro as a device that "stimulates collagen production." Additionally, in a video linked on your firm's website, your firm says that the Zemits Abigon Pro can "stimulate collagen regeneration [and] increase the production of elastin and hyaluronic acid." Therapeutic massagers regulated under 21 CFR 890.5660 are intended for medical purposes such as relieving minor muscle aches and pains. Because your devices are for different intended uses than legally marketed devices in that generic type of devices of therapeutic massagers regulated under 890.5660, the devices exceed the limitations described in 21 CFR 890.9(a) and are not exempt from premarket notification requirements. They are also therefore subject to the requirement under 21 CFR 807.81(a)(3)(i).

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

A follow up inspection will be required to evaluate whether corrections and/or corrective actions are adequate.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter 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. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal 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 address 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 (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Melissa Michurski, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 729267” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla at Rafael.padilla@fda.hhs.gov.

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. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.