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FDA 510(k)

SMILE

K-Number: K213629 · 2023-02-12

ApplicantNu Eyne Co., Ltd.
Decision Date2023-02-12
Product CodeQGL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMILE is the device name listed in this FDA 510(k) record. The listed applicant is Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2023-02-12 under 510(k) number K213629. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMILE?

SMILE is a medical device that received FDA 510(k) clearance on 2023-02-12. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K213629.

When did SMILE receive FDA 510(k) clearance?

SMILE received FDA 510(k) clearance on 2023-02-12, under 510(k) number K213629.

Who is the listed applicant for SMILE?

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

What is the FDA product code for SMILE?

The FDA product code for SMILE is QGL.

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.

NCT07700147Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular DegenerationNOT_YET_RECRUITING

Other records listing Nu Eyne 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.

K243289ADDNOX (BPSPM1)K242719ELEXIR 2.0 (ALLIVE3)K211380ElexirK192773ALLIVE

Related Devices (Code: QGL)

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.

K243289ADDNOX (BPSPM1)Nu Eyne Co., Ltd.K232991BT-1000Bistos Co., Ltd.K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc.

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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