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FDA 510(k)

Diode Laser Therapy System

K-Number: K192569 · 2019-12-13

ApplicantSan HE Lefis Electronics Co., Ltd.
Decision Date2019-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy System is a medical device manufactured by San HE Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under approval number K192569. 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 Therapy System?

Diode Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by San HE Lefis Electronics Co., Ltd.. The 510(k) number is K192569.

When was Diode Laser Therapy System approved by the FDA?

Diode Laser Therapy System received FDA 510(k) clearance on 2019-12-13, under approval number K192569.

What company makes Diode Laser Therapy System?

Diode Laser Therapy System is manufactured by San HE Lefis Electronics Co., Ltd..

What is the FDA product code for Diode Laser Therapy System?

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

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Related PubMed Literature

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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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