<?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>e2c497c0-0c92-4aea-9a47-063f3e5b54dd</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-12-20</publicVersionDate><devicePublishDate>2022-12-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>G346ES190</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>Epsilon USA</brandName><versionModelNumber>ES-19</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>917922762</dunsNumber><companyName>EPSILON EYE CARE PRIVATE LIMITED</companyName><deviceCount>1</deviceCount><deviceDescription>Epsilon Angled IOL Cutter (101 mm overall) Titanium
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</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>(909)984-4614</phone><phoneExtension xsi:nil="true"/><email>epsilonusa1@gmail.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>13489</gmdnCode><gmdnPTName>Ophthalmic suture scissors</gmdnPTName><gmdnPTDefinition>A hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HNF</productCode><productCodeName>Scissors, Ophthalmic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Dry Heat Sterilization</sterilizationMethod><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod><sterilizationMethod>Ethylene Oxide</sterilizationMethod></methodTypes></sterilization></device>