{"publicDeviceRecordKey":"7d09f36e-89a4-4244-ad16-91683189b3c7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2026-01-08T00:00:00.000Z","devicePublishDate":"2020-07-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B5863386","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Positively Clear Acne Clearing Blue Light","versionModelNumber":"BL2","catalogNumber":"3386","dunsNumber":"116909762","companyName":"Tria Laser Inc","deviceCount":1,"deviceDescription":"Positively Clear Acne Clearing Blue Light - Korea","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"1-877-321-8742","phoneExtension":null,"email":"customercare@triabeauty.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K160821","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62414","gmdnPTName":"Blue-light phototherapy lamp, home-use","gmdnPTDefinition":"A hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. This is a single-patient, reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OLP","productCodeName":"Over-The-Counter Powered Light Based Laser For Acne"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}