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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) 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. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K220103.

When did LED Therapy Device (Planar LED/Planar LED mini) receive FDA 510(k) clearance?

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

Who is the listed applicant for LED Therapy Device (Planar LED/Planar LED mini)?

The FDA 510(k) record lists Shenzhen Leaflife Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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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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