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FDA 510(k)

Diode Laser 808nm

K-Number: K192516 · 2019-12-10

ApplicantBeijing Superlaser Technology Co., Ltd.
Decision Date2019-12-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser 808nm is a medical device manufactured by Beijing Superlaser Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-10 under approval number K192516. 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 808nm?

Diode Laser 808nm is a medical device that received FDA 510(k) clearance on 2019-12-10. It is manufactured by Beijing Superlaser Technology Co., Ltd.. The 510(k) number is K192516.

When was Diode Laser 808nm approved by the FDA?

Diode Laser 808nm received FDA 510(k) clearance on 2019-12-10, under approval number K192516.

What company makes Diode Laser 808nm?

Diode Laser 808nm is manufactured by Beijing Superlaser Technology Co., Ltd..

What is the FDA product code for Diode Laser 808nm?

The FDA product code for Diode Laser 808nm is GEX. This falls under the Gastroenterology category.

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Other Devices by Beijing Superlaser Technology Co., Ltd.

K192519Multi-modality workstation K200042CO2 Laser System K193464ND:YAG Laser K251457Diode laser therapy device (VADER)

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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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