FDA 510(k)

ラピドメディカルレーザー（ラピドMED、ラピドデルマ、ラピドENT、ラピドポディア）

K番号: K240543 · 2024-10-24

決定日2024-10-24

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is the device name listed in this FDA 510(k) record. The listed applicant is Medency S.R.L.. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K240543. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Medency S.R.L.. The 510(k) number is K240543.

When did Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) receive FDA 510(k) clearance?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K240543.

Who is the listed applicant for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

The FDA 510(k) record lists Medency S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

The FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is GEX. This falls under the Gastroenterology category.

申請者としてMedency S.R.L.を記載するその他の記録

K232222プライモデンタルレーザー（プライモ、プライモコムフォート、プライモライト、プライモブルー、およびプライモトリプロ）

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。