[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MLP":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":110,"syncDates":115,"translation":122,"marketSummary":128,"recalls":144,"k510s":146,"pmas":168},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},4701,"MLP","Keratoprosthesis, Temporary Implant, Surgical Use","2","886.3400","OP","Ophthalmic","1","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":18,"fei_number":24,"registration_number":27},[19,20,21,22,23],"K902491","K895013","K261312","K842856","K910828",[25,26],"3014865","1038833",[25,26],"Y","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.620842+00:00",0,null,5,2,[],[39,47,55,63,71,77,84,90,97,103],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},2899,"電動式歯科用インプラント手術器具","Ⅱ","70965002",0.253731,0.63628,0.0284455,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":33,"vector_similarity":53,"score":54},4337,"歯科用インプラント手術器具","Ⅰ","70965001",0.239437,0.634375,0.0274254,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":33,"vector_similarity":61,"score":62},661,"体内用合成・炭素繊維補綴材","Ⅲ","33473103",0.223684,0.629592,0.0247253,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":33,"vector_similarity":69,"score":70},156,"体内用サージカルテープ","Ⅳ","34046000",0.298246,0.598927,0.0163934,{"medical_device_id":72,"generic_name":73,"class_classification":42,"jmdn_code":74,"name_similarity":75,"definition_similarity":33,"vector_similarity":76,"score":70},2836,"電動式ケラトーム","12222002",0.101695,0.71672,{"medical_device_id":78,"generic_name":79,"class_classification":58,"jmdn_code":80,"name_similarity":81,"definition_similarity":33,"vector_similarity":82,"score":83},547,"ヘパリン使用一時留置型人工血管","70487103",0.285714,0.561701,0.016129,{"medical_device_id":85,"generic_name":86,"class_classification":58,"jmdn_code":87,"name_similarity":88,"definition_similarity":33,"vector_similarity":89,"score":83},686,"人工角膜","42525000",0.175439,0.706943,{"medical_device_id":91,"generic_name":92,"class_classification":50,"jmdn_code":93,"name_similarity":94,"definition_similarity":33,"vector_similarity":95,"score":96},4058,"歯科インプラント補綴用器具","70722000",0.28125,0.588493,0.015873,{"medical_device_id":98,"generic_name":99,"class_classification":50,"jmdn_code":100,"name_similarity":101,"definition_similarity":33,"vector_similarity":102,"score":96},4171,"手動式ケラトーム","12222001",0.0895522,0.699076,{"medical_device_id":104,"generic_name":105,"class_classification":58,"jmdn_code":106,"name_similarity":107,"definition_similarity":33,"vector_similarity":108,"score":109},531,"外眼眼窩インプラント","70442000",0.134328,0.687792,0.015625,[111],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"HQM","Keratoprosthesis, Permanent Implant",4,{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":34,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":34,"reviewed_at":34,"created_at":127,"updated_at":127},"手術用一時的角膜プロテーゼ","本品は角膜移植手術等の際に一時的に角膜の代わりとして使用される人工角膜（角膜プロテーゼ）であり、術中の視認性を確保するために用いられる外科用インプラントです。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められています。これは、既存の同等の医療機器（プレディケートデバイス）との実質的同等性を示すことで市販が可能となる区分であり、クラスIIIに求められる市販前承認（PMA）よりも簡略化された審査プロセスとなっています。","claude-sonnet-5","1e872471c17687bb8ed28819f0ba6c610a164558159ecd4ed63e6fc3fae53985","2026-08-24T02:14:44.518901+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":142,"model_name":125,"created_at":143,"updated_at":143},"本製品コードにおける510(k)届出は累計約5件で、参入企業数は3社、直近5年間では約1件の届出が確認されており、最新の判定は2026年7月となっています。PMA（市販前承認）の実績は確認されていません。不具合報告は累計約2件で、内訳は傷害が1件、その他が1件、死亡・不具合（Malfunction）は確認されておらず、直近5年間の報告はありません。回収については累計件数が確認されていません。",{"pma":131,"k510":132,"as_of":136,"events":137,"recalls":139,"top_problems":141},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":133,"latest":134,"applicants":135},1,"2026-07-24",3,"2026-08",{"death":33,"other":133,"total":36,"injury":133,"last5y":33,"malfunction":33,"latest_month":138},"2008-01",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":140},[],[],"62a439e4848ee8370a034209498a4933a4804aa43c161b474a81f30e947535a3","2026-08-24T04:54:58.317174+00:00",{"items":145,"total":33},[],{"items":147,"total":35},[148,154,158,162,165],{"k_number":21,"device_name":149,"applicant":150,"decision_date":134,"clearance_type":151,"decision_code":152,"statement_or_summary":153},"Temporary Keratoprosthesis (QuickSet TKP)","Eyekon Medical, Inc.","Traditional","SESE","Summary",{"k_number":23,"device_name":155,"applicant":156,"decision_date":157,"clearance_type":151,"decision_code":152,"statement_or_summary":34},"LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS","Ocular Instruments, Inc.","1991-08-21",{"k_number":19,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":151,"decision_code":152,"statement_or_summary":34},"ECKHARDT TEMPORARY KERATOPROSTHESIS","Dutch Ophthalmic USA, Inc.","1990-06-26",{"k_number":20,"device_name":163,"applicant":156,"decision_date":164,"clearance_type":151,"decision_code":152,"statement_or_summary":34},"COBO TEMPORARY KERATOPROSTHESIS","1989-10-31",{"k_number":22,"device_name":166,"applicant":156,"decision_date":167,"clearance_type":151,"decision_code":152,"statement_or_summary":34},"LANDERS-FOULKS TEMP. KERATOPROSTHESIS","1984-12-18",{"items":169,"total":33},[]]