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FDA 510(k)

Matrix LS-40 CO2 Laser System

K-Number: K161356 · 2016-09-09

ApplicantShanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Decision Date2016-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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