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FDA 510(k)

TRIXEL CO2 LASER

K-Number: K110434 · 2011-04-19

ApplicantBEIJING SYNTECH LASER CO., LTD.
Decision Date2011-04-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIXEL CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is BEIJING SYNTECH LASER CO., LTD.. It received FDA 510(k) clearance on 2011-04-19 under 510(k) number K110434. 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 TRIXEL CO2 LASER?

TRIXEL CO2 LASER is a medical device that received FDA 510(k) clearance on 2011-04-19. The listed applicant is BEIJING SYNTECH LASER CO., LTD.. The 510(k) number is K110434.

When did TRIXEL CO2 LASER receive FDA 510(k) clearance?

TRIXEL CO2 LASER received FDA 510(k) clearance on 2011-04-19, under 510(k) number K110434.

Who is the listed applicant for TRIXEL CO2 LASER?

The FDA 510(k) record lists BEIJING SYNTECH LASER CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIXEL CO2 LASER?

The FDA product code for TRIXEL CO2 LASER is GEX. This falls under the Gastroenterology category.

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Other records listing BEIJING SYNTECH LASER CO., LTD. as applicant

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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