[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HLX":3},{"classification":4,"mappedDevices":44,"similarCandidates":45,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":130,"recalls":144,"k510s":146,"pmas":215},{"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":39,"updated_at":40,"recall_count":41,"latest_recall_date":42,"k510_count":43,"pma_count":41,"event_count":41},373,"HLX","Photostimulator, Ac-Powered","2","886.1630","OP","Ophthalmic","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":37,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":38},{"k_number":17},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35],"K914163","K983983","K810699","K822915","K822919","K925741","K833446","K873990","K830770","K853812","K812331","K914393","K003442","K790637","K831231","K832762","K822923","K822922","N","Y","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:47.318533+00:00",0,null,18,[],[46,54,62,69,76,83,90,96,103,109],{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":41,"vector_similarity":52,"score":53},2836,"電動式ケラトーム","Ⅱ","12222002",0.264706,0.628546,0.0310544,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":41,"vector_similarity":60,"score":61},830,"電動式心肺人工蘇生器","Ⅲ","35309000",0.211538,0.598885,0.0227273,{"medical_device_id":63,"generic_name":64,"class_classification":49,"jmdn_code":65,"name_similarity":66,"definition_similarity":41,"vector_similarity":67,"score":68},1775,"送気送水機能付バッテリー式内視鏡用光源装置","35906002",0.107143,0.648856,0.0163934,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":41,"vector_similarity":75,"score":68},3950,"加速装置用電動式患者台","Ⅰ","40687000",0.265306,0.554958,{"medical_device_id":77,"generic_name":78,"class_classification":72,"jmdn_code":79,"name_similarity":80,"definition_similarity":41,"vector_similarity":81,"score":82},3260,"X線透視画像記録用フォトスポットカメラ","40964000",0.0779221,0.643547,0.016129,{"medical_device_id":84,"generic_name":85,"class_classification":49,"jmdn_code":86,"name_similarity":87,"definition_similarity":41,"vector_similarity":88,"score":89},2291,"電動式吸引用ポンプ","36616040",0.210526,0.635353,0.015873,{"medical_device_id":91,"generic_name":92,"class_classification":72,"jmdn_code":93,"name_similarity":94,"definition_similarity":41,"vector_similarity":95,"score":89},3949,"加速装置用非電動式患者台","40686000",0.26,0.503326,{"medical_device_id":97,"generic_name":98,"class_classification":49,"jmdn_code":99,"name_similarity":100,"definition_similarity":41,"vector_similarity":101,"score":102},1774,"送気送水機能付外部電源式内視鏡用光源装置","35158002",0.1125,0.634601,0.015625,{"medical_device_id":104,"generic_name":105,"class_classification":49,"jmdn_code":106,"name_similarity":107,"definition_similarity":41,"vector_similarity":108,"score":102},2555,"電動式植皮刀","11179000",0.257143,0.561392,{"medical_device_id":110,"generic_name":111,"class_classification":49,"jmdn_code":112,"name_similarity":113,"definition_similarity":41,"vector_similarity":114,"score":115},2885,"電動式手術用ドリルモータ","43915000",0.25,0.521995,0.0153846,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":125,"definition_ja":42,"commentary_ja":126,"model_name":127,"source_hash":128,"reviewed_by":42,"reviewed_at":42,"created_at":129,"updated_at":129},"交流電源式光刺激装置","本品は眼科領域で使用される、交流電源で駆動する光刺激装置です。米国ではクラスIIに分類されており、市販に先立って市販前届出（510(k)）による審査を受け、既存の同等品との実質的同等性を示す必要があります。","claude-sonnet-5","d6c8bacecf114c6d11c8a4df04d85cad70136010f2ff2f8593a4d8a65d31ab6b","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":131,"stats":132,"stats_hash":142,"model_name":127,"created_at":143,"updated_at":143},"本製品区分の510(k)は累計約20件、申請企業数は13社であり、直近5年間の届出実績は確認されていません。最新の判定は2001年5月となっています。不具合報告および回収については、いずれも累計件数0件で、報告・実施の事例は確認されていません。",{"pma":133,"k510":134,"as_of":137,"events":138,"recalls":139,"top_problems":141},{"latest":42,"originals":41,"supplements":41},{"total":43,"last5y":41,"latest":135,"applicants":136},"2001-05-04",13,"2026-08",{"death":41,"other":41,"total":41,"injury":41,"last5y":41,"malfunction":41,"latest_month":42},{"total":41,"last5y":41,"latest":42,"class_i":41,"class_ii":41,"class_iii":41,"top_root_causes":140},[],[],"db81dfdede8a558af9f6b0749409525fb1c4ebdc2cd0d8d376006ab8dfd3daf3","2026-08-24T04:32:35.506862+00:00",{"items":145,"total":41},[],{"items":147,"total":43},[148,154,157,161,166,170,174,178,182,186,190,193,197,199,201,203,207,211],{"k_number":30,"device_name":149,"applicant":150,"decision_date":135,"clearance_type":151,"decision_code":152,"statement_or_summary":153},"MODIFICATION TO EDI VERIS SYSTEM","Electro-Diagnostic Imaging, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":155,"applicant":150,"decision_date":156,"clearance_type":151,"decision_code":152,"statement_or_summary":153},"EDI VERIS SYSTEM","1999-02-03",{"k_number":23,"device_name":158,"applicant":159,"decision_date":160,"clearance_type":151,"decision_code":152,"statement_or_summary":153},"CLARUS ENDOSCOPIC HOOK KNIFE","Clarus Medical Systems, Inc.","1993-08-24",{"k_number":29,"device_name":162,"applicant":163,"decision_date":164,"clearance_type":151,"decision_code":152,"statement_or_summary":165},"RETINA TESTER","Retina Tester","1992-03-02","Statement",{"k_number":18,"device_name":167,"applicant":168,"decision_date":169,"clearance_type":151,"decision_code":152,"statement_or_summary":165},"SCOPTOPIC SENSITIVITY TEST-1[SST-1]","Lkc Technologies, Inc.","1991-10-25",{"k_number":25,"device_name":171,"applicant":172,"decision_date":173,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"IRAS EDS INTERFEROMETRIC STIMULATOR","Randwal Instrument Co., Inc.","1988-02-05",{"k_number":27,"device_name":175,"applicant":176,"decision_date":177,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)","Biosan Laboratories, Inc.","1985-11-01",{"k_number":24,"device_name":179,"applicant":180,"decision_date":181,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"DOWNING SPECTRAL ILLUMINATOR","Vision Health Technology","1984-03-12",{"k_number":33,"device_name":183,"applicant":184,"decision_date":185,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"MILLER\u002FNADLER GLARE TESTER","Titmus Optical, Inc.","1983-09-29",{"k_number":32,"device_name":187,"applicant":188,"decision_date":189,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"LED GOGGLES","Cadwell Laboratories, Inc.","1983-05-16",{"k_number":26,"device_name":191,"applicant":188,"decision_date":192,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"CONTRAST SENSITIVITY EQUIPMENT","1983-04-28",{"k_number":34,"device_name":194,"applicant":195,"decision_date":196,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"5012 PARABOLIC STIMULATOR","Life-Tech Intl., Inc.","1982-12-28",{"k_number":35,"device_name":198,"applicant":195,"decision_date":196,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"5011 GANZFELD STIMULATOR",{"k_number":22,"device_name":200,"applicant":195,"decision_date":196,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"5010 VISUSTIM",{"k_number":21,"device_name":202,"applicant":195,"decision_date":196,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"5031 BRIGHT FLASH STIMULATOR",{"k_number":28,"device_name":204,"applicant":205,"decision_date":206,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"VTS-1000 VISUAL TESTING SYSTEM","Nicolet Biomedical Instruments","1981-11-16",{"k_number":20,"device_name":208,"applicant":209,"decision_date":210,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM","Visidyne Corp.","1981-06-09",{"k_number":31,"device_name":212,"applicant":213,"decision_date":214,"clearance_type":151,"decision_code":152,"statement_or_summary":42},"COMPUTERIZED ELECTRO-OCULOGRAPH","Potomac Medical System","1979-08-28",{"items":216,"total":41},[]]