[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OUH":3},{"classification":4,"mappedDevices":54,"similarCandidates":55,"relatedClassifications":136,"syncDates":219},{"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":47,"updated_at":48,"recall_count":49,"latest_recall_date":50,"k510_count":51,"pma_count":52,"event_count":53},6188,"OUH","Skin Resurfacing Rf Applicator","2","878.4400","SU","General, Plastic Surgery","1","Skin resurfacing",false,{"openfda":16,"definition":13,"device_name":7,"review_code":44,"device_class":8,"implant_flag":45,"product_code":6,"review_panel":10,"gmp_exempt_flag":45,"third_party_flag":45,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":44,"life_sustain_support_flag":45,"medical_specialty_description":11,"summary_malfunction_reporting":46},{"k_number":17,"fei_number":23,"registration_number":41},[18,19,20,21,22],"K150409","K130501","K142833","K120513","K101510",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"3018242561","3010363436","3013917867","3043140693","3015506965","3008085016","3008397795","3006985163","3014656892","3013602304","3030495752","3007535734","3012204368","3015151147","3033715699","3031944951","3002807555",[24,25,26,27,28,29,31,32,33,34,35,36,37,38,42,39,43],"3008729892","1064858","","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",1,"2020-11-18",5,0,8,[],[56,65,74,82,91,99,106,113,120,128],{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},313,"脳用アフターローディング式ブラキセラピー装置アプリケータ","Ⅳ","38413000",0.262295,0.0197628,0.654217,0.0287904,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},872,"直腸・肛門用手動式ブラキセラピー装置アプリケータ","Ⅲ","38430000",0.213115,0.0275862,0.665966,0.0282832,{"medical_device_id":75,"generic_name":76,"class_classification":59,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},315,"血管用アフターローディング式ブラキセラピー装置アプリケータ","38433000",0.211268,0.019802,0.675091,0.0281581,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},4367,"医科用捲綿子","Ⅰ","10172000",0.25,0.0161812,0.652354,0.0280063,{"medical_device_id":92,"generic_name":93,"class_classification":68,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},873,"直腸・肛門用アフターローディング式ブラキセラピー装置アプリケータ","38431000",0.214286,0.0187266,0.661455,0.0272711,{"medical_device_id":100,"generic_name":101,"class_classification":68,"jmdn_code":102,"name_similarity":95,"definition_similarity":103,"vector_similarity":104,"score":105},869,"前立腺用アフターローディング式ブラキセラピー装置アプリケータ","38427000",0.0188679,0.652131,0.025487,{"medical_device_id":107,"generic_name":108,"class_classification":68,"jmdn_code":109,"name_similarity":110,"definition_similarity":103,"vector_similarity":111,"score":112},861,"頸部用アフターローディング式ブラキセラピー装置アプリケータ","38419000",0.223881,0.6471,0.0253815,{"medical_device_id":114,"generic_name":115,"class_classification":68,"jmdn_code":116,"name_similarity":78,"definition_similarity":117,"vector_similarity":118,"score":119},865,"胆管用アフターローディング式ブラキセラピー装置アプリケータ","38423000",0.0189394,0.651484,0.0244484,{"medical_device_id":121,"generic_name":122,"class_classification":85,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":127},4370,"未滅菌吸収材付アプリケータ","33721000",0.210526,0.0421053,0.647657,0.0240999,{"medical_device_id":129,"generic_name":130,"class_classification":68,"jmdn_code":131,"name_similarity":132,"definition_similarity":133,"vector_similarity":134,"score":135},863,"食道用アフターローディング式ブラキセラピー装置アプリケータ","38421000",0.208333,0.018797,0.648433,0.0237093,[137,141,145,149,153,157,161,165,169,173,177,181,184,187,191,194,197,200,204,207,210,213,216],{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"GEI","Electrosurgical, Cutting & Coagulation & Accessories",2312,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"PBX","Massager, Vacuum, Radio Frequency Induced Heat",79,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"NEY","System, Ablation, Microwave And Accessories",68,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"OCL","Surgical Device, For Cutting, Coagulation, And\u002FOr Ablation Of Tissue, Including Cardiac Tissue",54,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"NUJ","Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed",37,{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"JOS","Electrode, Electrosurgical",36,{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"HAM","Apparatus, Electrosurgical",31,{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"OAB","Low Energy Direct Current Thermal Ablation System",14,{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"JOT","Electrode, Gel, Electrosurgical",9,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"NTB","System, Ablation, Ultrasound And Accessories",6,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"DWG","Electrosurgical Device",4,{"product_code":182,"device_name":183,"device_class":8,"k510_count":180},"ONQ","Electrosurgical Coagulation For Aesthetic",{"product_code":185,"device_name":186,"device_class":8,"k510_count":180},"QVJ","Low Power Electrosurgical Devices For Skin Lesion Destruction",{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"BWA","Unit, Electrosurgical And Coagulation, With Accessories",3,{"product_code":192,"device_name":193,"device_class":8,"k510_count":190},"MUK","Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue",{"product_code":195,"device_name":196,"device_class":8,"k510_count":190},"ODR","Electrosurgical Patient Return Electrode",{"product_code":198,"device_name":199,"device_class":8,"k510_count":190},"OUB","Instrument For Treatment Of Hyperhidrosis",{"product_code":201,"device_name":202,"device_class":8,"k510_count":203},"MWY","System, Microwave, Hair Removal",2,{"product_code":205,"device_name":206,"device_class":8,"k510_count":49},"NVJ","Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women",{"product_code":208,"device_name":209,"device_class":8,"k510_count":49},"PDG","Electrosurgical Vessel And\u002FOr Tissue Sealer. With Built-In Generator.",{"product_code":211,"device_name":212,"device_class":8,"k510_count":49},"QUQ","Knife, Intraocular Pressure Lowering",{"product_code":214,"device_name":215,"device_class":8,"k510_count":52},"MUL","Generator, Electrosurgical, Coagulation, Cancer",{"product_code":217,"device_name":218,"device_class":8,"k510_count":52},"SFQ","Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision",{"510k":220,"classification":221,"enforcement":222,"event":223,"pma":224,"warning_letter":225},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]