FDA 510(k)

二氧化碳激光治療系統

K 號：K162398 · 2017-07-06

申請人Beijing Sincoheren Science and Technology Development Co.

決定日期2017-07-06

產品代碼ONG

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

CO2 Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K162398. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CO2 Laser Therapy Systems?

CO2 Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K162398.

When did CO2 Laser Therapy Systems receive FDA 510(k) clearance?

CO2 Laser Therapy Systems received FDA 510(k) clearance on 2017-07-06, under 510(k) number K162398.

Who is the listed applicant for CO2 Laser Therapy Systems?

The FDA 510(k) record lists Beijing Sincoheren Science and Technology Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy Systems?

The FDA product code for CO2 Laser Therapy Systems is ONG.

其他以 Beijing Sincoheren Science and Technology Development Co. 為申請人之記錄

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。

K163123Q-Switched Neodymium:YAG 激光治療系統

相關器械（代碼：ONG）

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。

K252155AVAVA™ 皮膚治療系統AVAVA, Inc.K244060eCO2 3DLutronic Corporation K251031纖維雷射治療系統（HS-232，HS-233）Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ 皮膚治療系統AVAVA, Inc.K233550MOSAIC 3D（外科雷射）Lutronic Aesthetic K223871美麗雅皮膚治療系統AVAVA, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。