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FDA 510(k)

Diode Laser Therapy Systems

K-Number: K220381 · 2022-05-20

ApplicantBeijing Lasertell Medical Co., Ltd.
Decision Date2022-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Systems is a medical device manufactured by Beijing Lasertell Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-05-20 under approval number K220381. 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 Systems?

Diode Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2022-05-20. It is manufactured by Beijing Lasertell Medical Co., Ltd.. The 510(k) number is K220381.

When was Diode Laser Therapy Systems approved by the FDA?

Diode Laser Therapy Systems received FDA 510(k) clearance on 2022-05-20, under approval number K220381.

What company makes Diode Laser Therapy Systems?

Diode Laser Therapy Systems is manufactured by Beijing Lasertell Medical Co., Ltd..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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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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