[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KYE":3},{"classification":4,"mappedDevices":61,"similarCandidates":62,"relatedClassifications":134,"syncDates":135,"translation":142,"marketSummary":148,"recalls":163,"k510s":165,"pmas":210},{"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":55,"updated_at":56,"recall_count":57,"latest_recall_date":58,"k510_count":59,"pma_count":57,"event_count":60},6755,"KYE","Inserter\u002FRemover Contact Lens","1","886.5420","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":53,"product_code":6,"review_panel":10,"gmp_exempt_flag":53,"third_party_flag":53,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":53,"medical_specialty_description":11,"summary_malfunction_reporting":54},{"k_number":17,"fei_number":30,"registration_number":48},[18,19,20,21,22,23,24,25,26,27,28,29],"K780931","K850984","K780663","K872567","K830738","K872591","K871130","K830496","K782140","K870072","K780664","K850983",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"2518410","1937310","3038910345","1000160574","3010676356","3002513507","3015427564","3041506752","1523955","1000375210","1315522","3011919098","1000139415","3004216008","3006633372","3026961547","3007137643",[31,49,32,33,50,37,35,41,38,39,40,42,51,45,46,47,52],"1722370","8040278","2085143","8022166","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:49.029844+00:00",0,null,12,1,[],[63,71,79,87,94,101,108,114,121,128],{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":57,"vector_similarity":69,"score":70},4252,"眼内レンズ挿入器","Ⅰ","36061001",0.358974,0.785716,0.0327869,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":57,"vector_similarity":77,"score":78},1073,"再使用可能な非視力補正用色付コンタクトレンズ","Ⅲ","47837000",0.319149,0.694724,0.0310245,{"medical_device_id":80,"generic_name":81,"class_classification":82,"jmdn_code":83,"name_similarity":84,"definition_similarity":57,"vector_similarity":85,"score":86},2339,"コンタクトレンズ消毒器","Ⅱ","10995000",0.294118,0.721838,0.0307984,{"medical_device_id":88,"generic_name":89,"class_classification":82,"jmdn_code":90,"name_similarity":91,"definition_similarity":57,"vector_similarity":92,"score":93},2865,"単回使用眼内レンズ挿入器","36061002",0.28,0.759845,0.0304147,{"medical_device_id":95,"generic_name":96,"class_classification":74,"jmdn_code":97,"name_similarity":98,"definition_similarity":57,"vector_similarity":99,"score":100},1055,"再使用可能な視力補正用コンタクトレンズ","36055000",0.288462,0.704321,0.0303309,{"medical_device_id":102,"generic_name":103,"class_classification":74,"jmdn_code":104,"name_similarity":105,"definition_similarity":57,"vector_similarity":106,"score":107},644,"挿入器付後房レンズ","35658400",0.306122,0.689494,0.03031,{"medical_device_id":109,"generic_name":110,"class_classification":82,"jmdn_code":111,"name_similarity":76,"definition_similarity":57,"vector_similarity":112,"score":113},2907,"検査用コンタクトレンズ","34651010",0.669886,0.0294624,{"medical_device_id":115,"generic_name":116,"class_classification":74,"jmdn_code":117,"name_similarity":118,"definition_similarity":57,"vector_similarity":119,"score":120},1056,"単回使用視力補正用コンタクトレンズ","37581000",0.232143,0.697695,0.0285425,{"medical_device_id":122,"generic_name":123,"class_classification":74,"jmdn_code":124,"name_similarity":125,"definition_similarity":57,"vector_similarity":126,"score":127},1054,"再使用可能な視力補正用色付コンタクトレンズ","32803000",0.258621,0.683946,0.0283816,{"medical_device_id":129,"generic_name":130,"class_classification":74,"jmdn_code":131,"name_similarity":98,"definition_similarity":57,"vector_similarity":132,"score":133},1068,"角膜矯正用コンタクトレンズ","47926000",0.677211,0.0281914,[],{"510k":136,"classification":137,"enforcement":138,"event":139,"pma":140,"warning_letter":141},"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":143,"definition_ja":58,"commentary_ja":144,"model_name":145,"source_hash":146,"reviewed_by":58,"reviewed_at":58,"created_at":147,"updated_at":147},"コンタクトレンズ着脱器","本品は、コンタクトレンズの装着・取り外しを補助するために用いられる器具です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分に該当します。これは、安全性および有効性を確保するための規制上のリスクが低いと判断される機器であることを意味します。","claude-sonnet-5","7ed6fb24b5bc70a68c1d4ac26791f095ba8ea010498dca3151dd33490c9d7892","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":149,"stats":150,"stats_hash":161,"model_name":145,"created_at":162,"updated_at":162},"本製品コードにおける510(k)の累計件数は12件で、8社が参入していますが、直近5年間の届出はなく、最新の判定は1987年8月です。不具合報告は累計1件で、傷害報告が1件確認されていますが、直近5年間の報告はなく、最新の報告は2018年2月です。回収については累計0件であり、該当する事例は確認されていません。",{"pma":151,"k510":152,"as_of":155,"events":156,"recalls":158,"top_problems":160},{"latest":58,"originals":57,"supplements":57},{"total":59,"last5y":57,"latest":153,"applicants":154},"1987-08-10",8,"2026-08",{"death":57,"other":57,"total":60,"injury":60,"last5y":57,"malfunction":57,"latest_month":157},"2018-02",{"total":57,"last5y":57,"latest":58,"class_i":57,"class_ii":57,"class_iii":57,"top_root_causes":159},[],[],"f8434e1abb7dbe18f5e63158ee86975310bf399f83c5fa67a61b63b227b8663c","2026-08-24T04:49:04.081036+00:00",{"items":164,"total":57},[],{"items":166,"total":59},[167,172,175,179,183,187,189,193,197,201,205,208],{"k_number":21,"device_name":168,"applicant":169,"decision_date":153,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"SOFT CONTACT LENS REMOVER","Magnivision, Inc.","Traditional","SESE",{"k_number":23,"device_name":173,"applicant":169,"decision_date":174,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"HARD CONTACT LENS REMOVER. ITEM #289","1987-08-04",{"k_number":24,"device_name":176,"applicant":177,"decision_date":178,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"CONTACT LENS TWEEZERS","S. M. C. Medi-Tech Corp.","1987-05-12",{"k_number":27,"device_name":180,"applicant":181,"decision_date":182,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"SUMMIT OPTICS CONTACT LENS REMOVER","Dayton Mfg. Co.","1987-02-12",{"k_number":19,"device_name":184,"applicant":185,"decision_date":186,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"MARLIN SOFT LENS HANDLER","Marlin Industries","1985-09-10",{"k_number":29,"device_name":188,"applicant":185,"decision_date":186,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"MARLIN SOFT LENS TWEEZER",{"k_number":22,"device_name":190,"applicant":191,"decision_date":192,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"LENSERT CONTACT LENS CLEANING & INSERT","Jermyn Specialties of California","1983-06-10",{"k_number":25,"device_name":194,"applicant":195,"decision_date":196,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"DMV ANGLER","Dmv Contact Lens Co.","1983-03-09",{"k_number":26,"device_name":198,"applicant":199,"decision_date":200,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"REMOVER, SOFT-SERT CONTACT LENS","Mcmurray and Pendergost","1979-02-12",{"k_number":18,"device_name":202,"applicant":203,"decision_date":204,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"SOFT LENS INSERTER","Soft-Sert","1978-06-28",{"k_number":28,"device_name":206,"applicant":195,"decision_date":207,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"SOFT LENS REMOVER\u002FINSERTER\u002FMANIPULATOR","1978-05-17",{"k_number":20,"device_name":209,"applicant":195,"decision_date":207,"clearance_type":170,"decision_code":171,"statement_or_summary":58},"CONTACT LENS REMOVER AND INSERTER",{"items":211,"total":57},[]]