<?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>55c2e9f6-e8ce-4519-adbe-b6d399e14858</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2022-10-24</publicVersionDate><devicePublishDate>2016-08-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08033945933623</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>08033945935375</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033945933623</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>carton</pkgType></identifier><identifier><deviceId>08033945935689</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033945935375</containsDINumber><pkgQuantity>2</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>carton</pkgType></identifier></identifiers><brandName>Single use Surgical Optical Fiber</brandName><versionModelNumber>OAF005501</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>436045833</dunsNumber><companyName>QUANTA SYSTEM SPA</companyName><deviceCount>1</deviceCount><deviceDescription>Single use Surgical Optical Fiber Ø 550 µm</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</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>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>47785</gmdnCode><gmdnPTName>Urogenital surgical laser system beam guide, single-use</gmdnPTName><gmdnPTDefinition>A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GEX</productCode><productCodeName>Powered Laser Surgical Instrument</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>