[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PUE":3},{"classification":4,"mappedDevices":57,"similarCandidates":58,"relatedClassifications":137,"syncDates":150},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":54,"updated_at":54,"recall_count":55,"latest_recall_date":56,"k510_count":55,"pma_count":55,"event_count":55},6282,"PUE","Biomicroscope, Slit-Lamp, Ac-Powered, Exempt","2","886.1850","OP","Ophthalmic","4","This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":18,"device_class":8,"implant_flag":52,"product_code":6,"review_panel":10,"gmp_exempt_flag":52,"third_party_flag":52,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":18,"life_sustain_support_flag":52,"medical_specialty_description":11,"summary_malfunction_reporting":53},{"fei_number":17,"registration_number":49},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"","3013158193","1000176188","3010610157","3013436538","3006105501","3020309552","1000114111","3006550126","3012162565","3027499529","3004095901","3011898560","3013846070","3004784203","3013316298","3001802794","3033858960","3014273520","3006252153","3017045523","3042023395","3005301392","3003951061","3002821232","3043520139","3005527296","3005755367","3020410096","3005785090","3021343245",[18,19,20,21,22,23,50,24,26,27,28,29,30,31,32,33,35,36,37,38,39,40,41,42,43,44,45,46,51,47,48],"1054713","9710516","N","Eligible","2026-08-18T05:52:53.233452+00:00",0,null,[],[59,68,77,85,92,100,107,115,122,130],{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},3426,"細隙灯顕微鏡","Ⅰ","35148000",0.431818,0.177083,0.604683,0.0293805,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},1795,"再使用可能な高周波処置用内視鏡能動器具","Ⅱ","70164010",0.0673077,0.214286,0.664273,0.0163934,{"medical_device_id":78,"generic_name":79,"class_classification":71,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},2568,"高周波処置用能動器具","70662000",0.0340909,0.218875,0.656099,0.016129,{"medical_device_id":86,"generic_name":87,"class_classification":62,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":84},3433,"外部電源式内視鏡用光源装置","35158001",0.266667,0.170082,0.565563,{"medical_device_id":93,"generic_name":94,"class_classification":71,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1796,"単回使用高周波処置用内視鏡能動器具","70164020",0.0761905,0.216891,0.651599,0.015873,{"medical_device_id":101,"generic_name":102,"class_classification":62,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":99},3434,"バッテリー式内視鏡用光源装置","35906001",0.265625,0.170576,0.55629,{"medical_device_id":108,"generic_name":109,"class_classification":71,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},2563,"バイポーラ電極","70655000",0.0526316,0.239915,0.635956,0.015625,{"medical_device_id":116,"generic_name":117,"class_classification":62,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":114},3865,"電動式内視鏡レンズ洗浄器","70466000",0.258621,0.172619,0.560545,{"medical_device_id":123,"generic_name":124,"class_classification":71,"jmdn_code":125,"name_similarity":126,"definition_similarity":127,"vector_similarity":128,"score":129},1872,"電動式軟組織生検キット","16835020",0.216667,0.16,0.552965,0.0153846,{"medical_device_id":131,"generic_name":132,"class_classification":71,"jmdn_code":133,"name_similarity":134,"definition_similarity":135,"vector_similarity":136,"score":129},2554,"一般的電気手術器","70647000",0.0447761,0.195789,0.624912,[138,142,146],{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"HJO","Biomicroscope, Slit-Lamp, Ac-Powered",108,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"MXK","Device, Analysis, Anterior Segment",23,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"NQE","Microscope, Specular",9,{"510k":151,"classification":152,"enforcement":153,"event":154,"pma":155,"warning_letter":156},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]