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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 a medical device manufactured by Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2023-02-12 under approval 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. It is manufactured by Nu Eyne Co., Ltd.. The 510(k) number is K213629.

When was SMILE approved by the FDA?

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

What company makes SMILE?

SMILE is manufactured by Nu Eyne Co., Ltd..

What is the FDA product code for SMILE?

The FDA product code for SMILE is QGL.

Other Devices by Nu Eyne Co., Ltd.

K192773ALLIVE K211380Elexir K242719ELEXIR 2.0 (ALLIVE3) K243289ADDNOX (BPSPM1)

Related Devices (Code: QGL)

DEN180041Monarch eTNS SystemNeurosigma, Inc. K232991BT-1000Bistos Co., Ltd. K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc. K243289ADDNOX (BPSPM1)Nu Eyne Co., Ltd.

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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