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FDA 510(k)

SMARTLUX

K-Number: K120460 · 2012-10-01

ApplicantMedmix Co., Ltd.
Decision Date2012-10-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTLUX 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 2012-10-01 under 510(k) number K120460. 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?

SMARTLUX is a medical device that received FDA 510(k) clearance on 2012-10-01. The listed applicant is Medmix Co., Ltd.. The 510(k) number is K120460.

When did SMARTLUX receive FDA 510(k) clearance?

SMARTLUX received FDA 510(k) clearance on 2012-10-01, under 510(k) number K120460.

Who is the listed applicant for SMARTLUX?

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?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Medmix Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221083Smartlux Mini

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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