<?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>3e32733c-b064-4849-a286-485e32f116af</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-06-29</publicVersionDate><devicePublishDate>2022-06-21</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B366U1LED100C03</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>EVERLUX</brandName><versionModelNumber>R02</versionModelNumber><catalogNumber>U1LED100C03</catalogNumber><dunsNumber>043555079</dunsNumber><companyName>Ecleris</companyName><deviceCount>1</deviceCount><deviceDescription>EVERLUX LIGHT SOURCE</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</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>786-483-7490</phone><phoneExtension xsi:nil="true"/><email>ytzielo@ecleris.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>32037</gmdnCode><gmdnPTName>General-purpose light source</gmdnPTName><gmdnPTDefinition>A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EQH</productCode><productCodeName>Source, Carrier, Fiberoptic Light</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="75"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="35"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="106"/><storageHandlingLow unit="KiloPascal" value="70"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="-30"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="KiloPascal" value="106"/><storageHandlingLow unit="KiloPascal" value="50"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>