[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MYH":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":99,"syncDates":100,"translation":107,"marketSummary":113,"recalls":127,"k510s":129,"pmas":131},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":26,"event_count":26},7081,"MYH","System, Non-Coherent Light, Photodynamic Therapy","3","","Unknown","SU","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":11,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":20,"medical_specialty_description":10,"summary_malfunction_reporting":21},{"fei_number":16,"pma_number":17,"registration_number":19},[9],[18],"P010061",[9],"N","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-24T02:00:47.513022+00:00",0,null,1,[],[29,37,44,52,59,65,72,79,86,93],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},2475,"マイクロ波治療器","Ⅱ","11245000",0.290909,0.679816,0.0313188,{"medical_device_id":38,"generic_name":39,"class_classification":32,"jmdn_code":40,"name_similarity":41,"definition_similarity":24,"vector_similarity":42,"score":43},2470,"キセノン光線治療器","70606000",0.266667,0.69569,0.0310096,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},882,"生体組織内X線治療装置","Ⅲ","70604000",0.25,0.678826,0.0294181,{"medical_device_id":53,"generic_name":54,"class_classification":32,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},2465,"赤外線治療器","35147000",0.233333,0.706187,0.0290309,{"medical_device_id":60,"generic_name":61,"class_classification":32,"jmdn_code":62,"name_similarity":41,"definition_similarity":24,"vector_similarity":63,"score":64},2467,"炭素弧光灯治療器","34476000",0.657944,0.0286935,{"medical_device_id":66,"generic_name":67,"class_classification":32,"jmdn_code":68,"name_similarity":69,"definition_similarity":24,"vector_similarity":70,"score":71},2466,"紫外線治療器","35149000",0.225806,0.679769,0.0272059,{"medical_device_id":73,"generic_name":74,"class_classification":32,"jmdn_code":75,"name_similarity":76,"definition_similarity":24,"vector_similarity":77,"score":78},2551,"低周波治療器・キセノン光線治療器組合せ理学療法機器","70628000",0.234043,0.666185,0.0268468,{"medical_device_id":80,"generic_name":81,"class_classification":47,"jmdn_code":82,"name_similarity":83,"definition_similarity":24,"vector_similarity":84,"score":85},917,"眼科用レーザ光凝固装置","70634000",0.225352,0.674362,0.0264302,{"medical_device_id":87,"generic_name":88,"class_classification":32,"jmdn_code":89,"name_similarity":90,"definition_similarity":24,"vector_similarity":91,"score":92},2957,"家庭用炭素弧光灯治療器","71014000",0.235294,0.653847,0.0260135,{"medical_device_id":94,"generic_name":95,"class_classification":47,"jmdn_code":96,"name_similarity":69,"definition_similarity":24,"vector_similarity":97,"score":98},880,"非線形加速器システム","33073000",0.66115,0.0259916,[],{"510k":101,"classification":102,"enforcement":103,"event":104,"pma":105,"warning_letter":106},"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":108,"definition_ja":25,"commentary_ja":109,"model_name":110,"source_hash":111,"reviewed_by":25,"reviewed_at":25,"created_at":112,"updated_at":112},"非干渉光光線力学的療法装置","本品は米国においてクラスIIIに分類されており、市販前承認（PMA）の対象となる医療機器です。クラスIIIは人体へのリスクが最も高い区分とされ、有効性と安全性に関する十分な科学的証拠を提出し、FDAの厳格な審査を経て承認を取得する必要があります。","claude-sonnet-5","6f15d1f5b8e1a02e8129c02ab0366c830c329d737995bc5625b4e75c5e9bc7c6","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":114,"stats":115,"stats_hash":125,"model_name":110,"created_at":126,"updated_at":126},"本製品はPMA(市販前承認)の対象で、本承認が1件2004年7月に行われていますが、一部変更承認や510(k)の届出は確認されていません。不具合報告は累計約1件で、内容は傷害(Injury)によるものであり、最新の報告は2008年12月、直近5年間の報告は確認されていません。回収については累計・直近5年ともに確認されていません。",{"pma":116,"k510":118,"as_of":119,"events":120,"recalls":122,"top_problems":124},{"latest":117,"originals":26,"supplements":24},"2004-07-28",{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":24,"other":24,"total":26,"injury":26,"last5y":24,"malfunction":24,"latest_month":121},"2008-12",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":123},[],[],"162c10a8ce67a33f06c9437c09f64f0954aa4d3dd756f5a69f7ff7c51a4601e1","2026-08-24T04:57:04.90455+00:00",{"items":128,"total":24},[],{"items":130,"total":24},[],{"items":132,"total":26},[133],{"pma_number":18,"supplement_number":9,"trade_name":134,"applicant":135,"decision_date":117},"CURELIGHT BROADBAND (MODEL CURELIGHT 01)","Photocure Asa"]