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Stateフィールドに記載された特定の免除の制限を超えない場合、市販のために市販前届出（510(k)）を必要としない。","本製品はクラスIIに分類されていますが、米国の規制上は市販前届出（510(k)）が免除される品目とされています。これは21世紀治療法に基づき確立された手続きにより、一定の制限の範囲内であれば届出を行わずに市販できる区分に位置づけられていることを意味します。ただし、この届出免除は無条件ではなく、21 CFR 884.9に定める一般的な制限および当該製品コードに固有の制限の範囲内でのみ適用されます。","claude-sonnet-5","5375c23b7bc9e0f9c84c4eb092c30e41c27dcf90deaf5a18cc29e2c765ab86c3","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":151,"stats":152,"stats_hash":163,"model_name":147,"created_at":164,"updated_at":164},"本製品は届出免除（510(k) Exempt）の区分であり、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告は累計約2件で、いずれもMalfunction（不具合）に分類され、死亡・傷害の報告は確認されていません。主な問題としてはContamination（汚染）およびOptical 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