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FDA 510(k)

DIODE LASER

K-Number: K123483 · 2013-04-21

ApplicantBEIJING SYNTECH LASER CO., LTD.
Decision Date2013-04-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIODE 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 2013-04-21 under 510(k) number K123483. 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 DIODE LASER?

DIODE LASER is a medical device that received FDA 510(k) clearance on 2013-04-21. The listed applicant is BEIJING SYNTECH LASER CO., LTD.. The 510(k) number is K123483.

When did DIODE LASER receive FDA 510(k) clearance?

DIODE LASER received FDA 510(k) clearance on 2013-04-21, under 510(k) number K123483.

Who is the listed applicant for DIODE 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 DIODE LASER?

The FDA product code for DIODE 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.

K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMK110434TRIXEL CO2 LASER

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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