FDA 510(k)

皮膚科用二重線激光システム

K番号: K212478 · 2022-01-14

申請者Beijing Stelle Laser Technology Co., Ltd.

決定日2022-01-14

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

Dermatological diode laser system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Stelle Laser Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K212478. 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 Dermatological diode laser system?

Dermatological diode laser system is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Beijing Stelle Laser Technology Co., Ltd.. The 510(k) number is K212478.

When did Dermatological diode laser system receive FDA 510(k) clearance?

Dermatological diode laser system received FDA 510(k) clearance on 2022-01-14, under 510(k) number K212478.

Who is the listed applicant for Dermatological diode laser system?

The FDA 510(k) record lists Beijing Stelle Laser Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dermatological diode laser system?

The FDA product code for Dermatological diode laser system is GEX. This falls under the Gastroenterology category.

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。

皮膚科用二重線激光システム

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）

公式ソース