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FDA 510(k)

Smartlux Mini

K-Number: K221083 · 2022-07-12

ApplicantMedmix Co., Ltd.
Decision Date2022-07-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Smartlux Mini is the device name listed in this FDA 510(k) record. The listed applicant is Medmix Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K221083. 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 Smartlux Mini?

Smartlux Mini is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Medmix Co., Ltd.. The 510(k) number is K221083.

When did Smartlux Mini receive FDA 510(k) clearance?

Smartlux Mini received FDA 510(k) clearance on 2022-07-12, under 510(k) number K221083.

Who is the listed applicant for Smartlux Mini?

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

What is the FDA product code for Smartlux Mini?

The FDA product code for Smartlux Mini is GEX. This falls under the Gastroenterology category.

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Official Source

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