<?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>276829fe-26a0-4c77-a408-886cb1f64a91</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-01-09</publicVersionDate><devicePublishDate>2021-01-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B136MLB3000</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>Sun Nuclear MICRO+</brandName><versionModelNumber>MLB+300</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>122240021</dunsNumber><companyName>SUN NUCLEAR CORP.</companyName><deviceCount>1</deviceCount><deviceDescription>The MICRO+ MLG+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied. </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>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>40893</gmdnCode><gmdnPTName>Laser patient positioning system</gmdnPTName><gmdnPTDefinition>A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient&apos;s skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient&apos;s anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IWE</productCode><productCodeName>Monitor, Patient Position, Light-Beam</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>