FDA 510(k)

マトリックスLS-40CO2レーザーシステム

K番号: K161356 · 2016-09-09

申請者Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

決定日2016-09-09

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

Matrix LS-40 CO2 Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161356. 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 Matrix LS-40 CO2 Laser System?

Matrix LS-40 CO2 Laser System is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K161356.

When did Matrix LS-40 CO2 Laser System receive FDA 510(k) clearance?

Matrix LS-40 CO2 Laser System received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161356.

Who is the listed applicant for Matrix LS-40 CO2 Laser System?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Matrix LS-40 CO2 Laser System?

The FDA product code for Matrix LS-40 CO2 Laser System is GEX. This falls under the Gastroenterology category.

申請者としてShanghai Wonderful Opto-Electrics Tech.Co.,Ltdを記載するその他の記録

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