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FDA 510(k)

LED Therapy Device (Planar LED/Planar LED mini)

K-Number: K220103 · 2022-04-12

ApplicantShenzhen Leaflife Technology Co., Ltd.
Decision Date2022-04-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Therapy Device (Planar LED/Planar LED mini) is a medical device manufactured by Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under approval number K220103. 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 LED Therapy Device (Planar LED/Planar LED mini)?

LED Therapy Device (Planar LED/Planar LED mini) is a medical device that received FDA 510(k) clearance on 2022-04-12. It is manufactured by Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K220103.

When was LED Therapy Device (Planar LED/Planar LED mini) approved by the FDA?

LED Therapy Device (Planar LED/Planar LED mini) received FDA 510(k) clearance on 2022-04-12, under approval number K220103.

What company makes LED Therapy Device (Planar LED/Planar LED mini)?

LED Therapy Device (Planar LED/Planar LED mini) is manufactured by Shenzhen Leaflife Technology Co., Ltd..

What is the FDA product code for LED Therapy Device (Planar LED/Planar LED mini)?

The FDA product code for LED Therapy Device (Planar LED/Planar LED mini) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Official Source

View on FDA Database →

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

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