FDA 510(k)

Stellar M22 高強度脈衝光（IPL）及雷射系統

K 號：K193500 · 2020-01-16

決定日期2020-01-16

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Stellar M22 for Intense Pulsed Light (IPL) and Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K193500. 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.

常見問題

What is the Stellar M22 for Intense Pulsed Light (IPL) and Laser System?

Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Lumenis, Ltd.. The 510(k) number is K193500.

When did Stellar M22 for Intense Pulsed Light (IPL) and Laser System receive FDA 510(k) clearance?

Stellar M22 for Intense Pulsed Light (IPL) and Laser System received FDA 510(k) clearance on 2020-01-16, under 510(k) number K193500.

Who is the listed applicant for Stellar M22 for Intense Pulsed Light (IPL) and Laser System?

The FDA 510(k) record lists Lumenis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stellar M22 for Intense Pulsed Light (IPL) and Laser System?

The FDA product code for Stellar M22 for Intense Pulsed Light (IPL) and Laser System is GEX. This falls under the Gastroenterology category.

其他以 Lumenis, Ltd. 為申請人之記錄

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相關器械（代碼：GEX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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