[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-estar-technologies-ltd-716831-04222026":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},171,"estar-technologies-ltd-716831-04222026","Warning Letter","Estar Technologies Ltd",null,"Center for Biologics Evaluation and Research","Investigational Device Exemptions (IDE)\u002FPremarket Approval Application (PMA) Adulterated Device","2026-05-12","2026-04-22","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Festar-technologies-ltd-716831-04222026","CBER 26-716831","716831","BiologicsMedical Devices","Via UPS and EMAIL","Aaron Esteron","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via UPS and EMAIL\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">CBER 26-716831\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Biologics\u003Cbr>Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Aaron Esteron\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Chief Executive Officer and Founder\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Estar Technologies Ltd\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">15, Ha-Merkava\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Holon\u003C\u002Fspan> \u003Cspan class=\"postal-code\">5885111\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Israel\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:Aaron@estar-medical.com\"> Aaron@estar-medical.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Biologics Evaluation and Research\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>April 22, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>CBER 26-716831\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Dear Mr. Esteron:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale the Tropocells® PRP kit, Tropocells® PRF kit, Tropocells® TRS kit, Tropocells® PRFM kit, TropoVisc™ kit, Tropokine™ kit, and Cellenis® PRP kit (hereafter, “your devices”) 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), your devices are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.\u003C\u002Fp>\u003Cp>Based on information and records reviewed by FDA, including your websites at https:\u002F\u002Fwww.tropocells.com and https:\u002F\u002Festar-medical.com\u002F (last visited April 2026), your devices 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your introduction or delivery for introduction of your devices into interstate commerce, or the causing thereof is a prohibited act under section 301(a) of the Act, 21 U.S.C. § 331(a). Your devices 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 your devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).\u003C\u002Fp>\u003Cp>Of note, the TropoCells® PRP kit was cleared under premarket notification (510(k)) submission number BK110035 with the following indication, “safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and\u002For allograft bone prior to application to a bony defect for improving handling characteristics.” However, you include statements such as the following on your website, https:\u002F\u002Fwww.tropocells.com, regarding the uses of the Tropocells® PRP kit:\u003C\u002Fp>\u003Cp>“Tropocells® PRP is the ideal autologous technology for the healing of: musculoskeletal injuries, joint and osteoarthritis treatment, sports injuries, wound healing, ophthalmology, dentistry and oral surgery, and post-surgical recovery.”\u003C\u002Fp>\u003Cp>These represent major changes or modifications to the intended uses for this device and are changes or modifications that could significantly affect its safety or effectiveness. Therefore, premarket notification for this device is required. See 21 CFR 807.81(a)(3).\u003C\u002Fp>\u003Cp>For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the FDA. 21 C.F.R. § 807.81(b). The kind of information that you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Estar Technologies Ltd. should cease any activities that result in the misbranding or adulteration of the Tropocells® PRP kit, Tropocells® PRF kit, Tropocells® TRS kit, Tropocells® PRFM kit, TropoVisc™ kit, Tropokine™ kit, and Cellenis® PRP kit, such as the commercial distribution of the devices for the uses discussed above.\u003C\u002Fp>\u003Cp>Your firm should take prompt action to address any violations identified in this letter. Failure to promptly 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.\u003C\u002Fp>\u003Cp>Please notify our 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\u002For corrective actionsyour firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For 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 devices are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Melissa J. Mendoza\u003Cbr>Director\u003Cbr>Office of Compliance and Biologics Quality\u003Cbr>Center for Biologics Evaluation and Research\u003C\u002Fp>\u003Cp>Cc: Mr. Irving L. Wiesen, Esq\u003Cbr>US Agent\u003Cbr>Law Offices of Irving L. Wiesen PC.\u003Cbr>420 Lexington Avenue, Suite 2400\u003Cbr>New York, New York 10170\u003Cbr>lwiesen@Wiesenlaw.com\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia UPS and EMAIL\n\nReference #:\n\nCBER 26-716831\n\nProduct:\n\nBiologics\nMedical Devices\n\nRecipient:\n\nRecipient Name\n\nAaron Esteron\n\nRecipient Title\n\nChief Executive Officer and Founder\n\nEstar Technologies Ltd\n\n15, Ha-Merkava\n\nHolon 5885111\n\nIsrael\n\nAaron@estar-medical.com\n\nIssuing Office:\n\nCenter for Biologics Evaluation and Research\n\nUnited States\n\nWARNING LETTER\nApril 22, 2026\nCBER 26-716831\nDear Mr. Esteron:\nThe United States Food and Drug Administration (FDA) has learned that your firm is offering for sale the Tropocells® PRP kit, Tropocells® PRF kit, Tropocells® TRS kit, Tropocells® PRFM kit, TropoVisc™ kit, Tropokine™ kit, and Cellenis® PRP kit (hereafter, “your devices”) 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), your devices are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.\nBased on information and records reviewed by FDA, including your websites at https:\u002F\u002Fwww.tropocells.com and https:\u002F\u002Festar-medical.com\u002F (last visited April 2026), your devices 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your introduction or delivery for introduction of your devices into interstate commerce, or the causing thereof is a prohibited act under section 301(a) of the Act, 21 U.S.C. § 331(a). Your devices 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 your devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).\nOf note, the TropoCells® PRP kit was cleared under premarket notification (510(k)) submission number BK110035 with the following indication, “safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and\u002For allograft bone prior to application to a bony defect for improving handling characteristics.” However, you include statements such as the following on your website, https:\u002F\u002Fwww.tropocells.com, regarding the uses of the Tropocells® PRP kit:\n“Tropocells® PRP is the ideal autologous technology for the healing of: musculoskeletal injuries, joint and osteoarthritis treatment, sports injuries, wound healing, ophthalmology, dentistry and oral surgery, and post-surgical recovery.”\nThese represent major changes or modifications to the intended uses for this device and are changes or modifications that could significantly affect its safety or effectiveness. Therefore, premarket notification for this device is required. See 21 CFR 807.81(a)(3).\nFor a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the FDA. 21 C.F.R. § 807.81(b). The kind of information that you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.\nConclusion\nEstar Technologies Ltd. should cease any activities that result in the misbranding or adulteration of the Tropocells® PRP kit, Tropocells® PRF kit, Tropocells® TRS kit, Tropocells® PRFM kit, TropoVisc™ kit, Tropokine™ kit, and Cellenis® PRP kit, such as the commercial distribution of the devices for the uses discussed above.\nYour firm should take prompt action to address any violations identified in this letter. Failure to promptly 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.\nPlease notify our 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\u002For corrective actionsyour firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For 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 devices are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.\nSend 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.\nSincerely,\n\u002FS\u002F\nMelissa J. Mendoza\nDirector\nOffice of Compliance and Biologics Quality\nCenter for Biologics Evaluation and Research\nCc: Mr. Irving L. Wiesen, Esq\nUS Agent\nLaw Offices of Irving L. Wiesen PC.\n420 Lexington Avenue, Suite 2400\nNew York, New York 10170\nlwiesen@Wiesenlaw.com","2026-08-19T04:42:21.534+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2026-05-12T04:00:00Z\">05\u002F12\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-04-22T04:00:00Z\">04\u002F22\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Festar-technologies-ltd-716831-04222026\">Estar Technologies Ltd\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]