{"publicDeviceRecordKey":"900df90e-b156-4846-9ff8-eac8f15d3c1b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-05-22T00:00:00.000Z","devicePublishDate":"2023-06-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E2352171B1","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"E235DL0010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DentaLaze Kit","versionModelNumber":"DL001","catalogNumber":"DL001","dunsNumber":"054618202","companyName":"SHOFU DENTAL CORPORATION","deviceCount":10,"deviceDescription":"DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control \u0026 Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"760-736-3277","phoneExtension":null,"email":"customer-service@shofu.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K201387","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60341","gmdnPTName":"General/multiple surgical diode laser system","gmdnPTDefinition":"An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NVK","productCodeName":"Laser, Dental, Soft Tissue"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}