Tides Medical LLC

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WARNING LETTER

October 6, 2026

CBER 26-727246

Dear Mr. Spell:

The United States Food and Drug Administration (FDA) has learned that your firm is distributing APLICOR 3D in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product 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 to affect the structure or any function of the body.¹

FDA has reviewed information and records, including your website at https://www.tidesmedical.com/aplicor-3d/ (last visited October 2026), and determined that APLICOR 3D is 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) for these devices 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). APLICOR 3D is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of these devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Your firm has stated that the APLICOR 3D device is a Class I device exempt from the requirement of premarket notification. You have indicated that the APLICOR 3D device is a liquid medication dispenser under product code KYX and 21 CFR 880.6430. Devices classified under 21 CFR 880.6430, liquid medication dispenser, are exempt from premarket notification unless they exceed the limitations of exemptions at 21 CFR 880.9. However, there is evidence that APLICOR 3D is intended for uses that are different from those of legally marketed devices classified under 21 CFR 880.6430, liquid medication dispenser. 21 CFR 880.6430(a) states that a liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. However, your firm is distributing APLICOR 3D for the following intended uses:

• “APLICOR 3D is a hyper-personalized 3D bioprinting platform that uses a patient’s own adipose tissue to create customized grafts for acute and chronic wounds. With a single application, this system simplifies workflows and accelerates wound progression.”
• “APLICOR 3D is a single-use 3D bioprinting system that transforms autologous adipose tissue into a personalized graft, precisely matching the size and depth of a patient’s wound.”
• “APLICOR 3D is designed for use in treating acute and chronic wounds such as diabetic foot ulcers, venous stasis ulcers, pressure injuries, burns, and trauma.”

Because there is evidence that APLICOR 3D is intended for uses that are different from those of legally marketed devices classified under 21 CFR 880.6430, it exceeds the limitations described in 21 CFR 880.9 and is not exempt from premarket notification.

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 FDA. 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. FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.

Conclusion

Our office requests that Tides Medical LLC cease any activities that result in the misbranding or adulteration of APLICOR 3D, including the commercial distribution of these devices for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to promptly and adequately address this matter may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Please notify our office in writing within fifteen (15) 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 your firm has taken, which should address any systemic problems. 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 (15) 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 APLICOR 3D is not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Refer to the CBER number at the top of this letter when replying.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.

Sincerely,

/S/

Vincent Amatrudo
Acting Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

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1 FDA acknowledges receipt of your February 26, 2026, correspondence responding to the February 25, 2026, letter sent to your firm from FDA’s Center for Devices and Radiological Health.