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FDA 510(k)

醫用二極雷射除毛系統（型號：Milestone Smart-M，Milestone Standard-A）

K 號：K222800 · 2022-11-07

申請人Sanhe Laserconn Tech Co., Ltd.
決定日期2022-11-07
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

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe Laserconn Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222800. 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 Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Sanhe Laserconn Tech Co., Ltd.. The 510(k) number is K222800.

When did Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) receive FDA 510(k) clearance?

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222800.

Who is the listed applicant for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

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

What is the FDA product code for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)?

The FDA product code for Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is GEX. This falls under the Gastroenterology category.

相關臨床試驗

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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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官方來源

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