[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PKO":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":115,"syncDates":181,"translation":188,"marketSummary":195,"recalls":209,"k510s":211,"pmas":223},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":34},6934,"PKO","Transparent Patch For Use In Treatment Of Tattoos","2","878.4810","SU","General, Plastic Surgery","1","To reduce formation of bubbles during laser treatment of tattoos.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":20,"registration_number":24},[18,19],"K150212","K172689",[21,22,23],"3013840437","3011310987","3003407669",[25,21,22],"2135225","","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:47.318533+00:00",0,null,2,6,[],[37,46,54,61,69,76,85,92,100,107],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},2245,"粘着性透明創傷被覆・保護材","Ⅱ","17428000",0.190476,0.0828402,0.642982,0.0267427,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":51},925,"皮膚レーザスキャナ","Ⅲ","36775000",0.0163934,0.177489,0.68465,{"medical_device_id":55,"generic_name":56,"class_classification":40,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":51},2618,"歯科用多目的超音波治療器","70719000",0.273973,0.0979381,0.554453,{"medical_device_id":62,"generic_name":63,"class_classification":49,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},504,"穿刺部保護パッチ","70432000",0.0952381,0.0748663,0.683981,0.016129,{"medical_device_id":70,"generic_name":71,"class_classification":49,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":68},1134,"経頭蓋治療用磁気刺激装置","61124003",0.236111,0.169118,0.486355,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},3795,"皮膚用接着剤","Ⅰ","33492101",0.0172414,0.109589,0.658923,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":79,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":84},4443,"歯科根管治療用手術器具","71074001",0.228571,0.138889,0.508836,{"medical_device_id":93,"generic_name":94,"class_classification":49,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},490,"尿失禁治療テープ","70414000",0.212121,0.2,0.602029,0.015625,{"medical_device_id":101,"generic_name":102,"class_classification":79,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":99},4350,"デルマトーム皮膚接合用テープ","70967000",0.04,0.0903614,0.658694,{"medical_device_id":108,"generic_name":109,"class_classification":49,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1110,"腹膜透析用治療計画プログラム","41049003",0.222222,0.114504,0.431524,0.0153846,[116,120,124,128,132,136,140,144,148,151,155,159,162,165,168,172,175,178],{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"GEX","Powered Laser Surgical Instrument",2872,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"OHT","Light Based Over-The-Counter Hair Removal",162,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"OHS","Light Based Over The Counter Wrinkle Reduction",161,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"ONF","Powered Light Based Non-Laser Surgical Instrument With Thermal Effect",74,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"LNK","Laser For Gastro-Urology Use",60,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"OLP","Over-The-Counter Powered Light Based Laser For Acne",51,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"ONG","Powered Laser Surgical Instrument With MicrobeamFractional Output",35,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"NUV","Massager, Vacuum, Light Induced Heating",19,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"PDZ","Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"NVK","Laser, Dental, Soft Tissue",17,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"ONE","Powered Light Based Non-Laser Surgical Instrument",7,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"ONO","Neurosurgical Laser With Mr Thermography",{"product_code":163,"device_name":164,"device_class":8,"k510_count":33},"OYW","Laser, Cellulite Appearance",{"product_code":166,"device_name":167,"device_class":8,"k510_count":33},"QCY","Laser Absorbing Particles",{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"ORK","Laser Assisted Lipolysis",1,{"product_code":173,"device_name":174,"device_class":12,"k510_count":31},"NXF","Gas, Laser Generating",{"product_code":176,"device_name":177,"device_class":8,"k510_count":31},"OEL","Laser, Benign Prostatic Hyperplasia",{"product_code":179,"device_name":180,"device_class":8,"k510_count":31},"QHF","Energy Based Device For Treatment Of Tattoos",{"510k":182,"classification":183,"enforcement":184,"event":185,"pma":186,"warning_letter":187},"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":189,"definition_ja":190,"commentary_ja":191,"model_name":192,"source_hash":193,"reviewed_by":32,"reviewed_at":32,"created_at":194,"updated_at":194},"刺青レーザー治療用透明パッチ","入れ墨のレーザー治療中における気泡の形成を軽減するためのものである。","本品は、入れ墨のレーザー治療を受ける際に皮膚に貼付し、治療光の照射に伴って生じる気泡の発生を抑える目的で用いられる透明なパッチです。米国ではクラスIIに分類されており、市販前届出（510(k)）により有効性及び安全性が既存の類似機器と実質的に同等であることを示すことで市販が認められる審査区分に位置づけられています。","claude-sonnet-5","bd3d48a2d530e78ede1d118442d319601958da621493c8f26daeaf7b39a8ff6a","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":196,"stats":197,"stats_hash":207,"model_name":192,"created_at":208,"updated_at":208},"本製品区分は510(k)による市販前届出で、これまでに2件の届出があり、2社が申請しています。直近5年間の届出は確認されていません。不具合報告は累計約6件で、その内訳はすべて傷害（Injury）報告となっており、直近5年間では約2件、最新の報告は2025年5月です。回収の報告は確認されていません。",{"pma":198,"k510":199,"as_of":201,"events":202,"recalls":204,"top_problems":206},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":200,"applicants":33},"2017-11-29","2026-08",{"death":31,"other":31,"total":34,"injury":34,"last5y":33,"malfunction":31,"latest_month":203},"2025-05",{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":205},[],[],"b31a4089e4bb5b1868c487c162c1b8f91f2590aec93555bc2fc560aad4de0a3d","2026-08-24T05:13:39.867404+00:00",{"items":210,"total":31},[],{"items":212,"total":33},[213,219],{"k_number":19,"device_name":214,"applicant":215,"decision_date":200,"clearance_type":216,"decision_code":217,"statement_or_summary":218},"DESCRIBE PFD Patch","Merz North America, Inc.","Traditional","SESE","Summary",{"k_number":18,"device_name":220,"applicant":221,"decision_date":222,"clearance_type":216,"decision_code":217,"statement_or_summary":218},"DeScribe Transparent PFD Patch","On Light Sciences, Inc.","2015-04-20",{"items":224,"total":31},[]]