FDA 510(k)

Vydence ラーザーファミリー

K番号: K252753 · 2026-01-24

申請者Vydence Medical Industria E Commercio Ltda

決定日2026-01-24

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

Vydence Family of Lasers is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Commercio Ltda. It received FDA 510(k) clearance on 2026-01-24 under 510(k) number K252753. 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 Vydence Family of Lasers?

Vydence Family of Lasers is a medical device that received FDA 510(k) clearance on 2026-01-24. The listed applicant is Vydence Medical Industria E Commercio Ltda. The 510(k) number is K252753.

When did Vydence Family of Lasers receive FDA 510(k) clearance?

Vydence Family of Lasers received FDA 510(k) clearance on 2026-01-24, under 510(k) number K252753.

Who is the listed applicant for Vydence Family of Lasers?

The FDA 510(k) record lists Vydence Medical Industria E Commercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vydence Family of Lasers?

The FDA product code for Vydence Family of Lasers is GEX. This falls under the Gastroenterology category.

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Vydence ラーザーファミリー

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEX）

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