<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>4414a543-58d5-437a-8f97-a70a4e6da738</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2025-07-21</publicVersionDate><devicePublishDate>2023-03-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08058773562937</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>18058773592931</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08058773562937</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>6 Boxes Carton</pkgType></identifier></identifiers><brandName>Lipogems Ortho Kit 60 + Tray</brandName><versionModelNumber>LG OK 60 T</versionModelNumber><catalogNumber>LG OK 60 T</catalogNumber><dunsNumber>431081002</dunsNumber><companyName>LIPOGEMS INTERNATIONAL SPA</companyName><deviceCount>1</deviceCount><deviceDescription>Lipogems Ortho Kit 60cc + Tray</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+390237072408</phone><phoneExtension xsi:nil="true"/><email>info@lipogems.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>56627</gmdnCode><gmdnPTName>Autologous adipose tissue noninvasive processing set</gmdnPTName><gmdnPTDefinition>A noninvasive collection of non-powered devices designed as a closed system for the collection and processing (e.g., filtering, washing) of autologous fat tissue for reinjection into the patient from whom it was taken (autologous lipotransfer) for aesthetic body contouring. It consists of containers (typically filtration and waste collection bags) and connection accessories (e.g., connectors, tubing); it does not include invasive needles/cannulae. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes/><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>