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FDA 510(k)

ADDNOX (BPSPM1)

K-Number: K243289 · 2025-01-16

ApplicantNu Eyne Co., Ltd.
Decision Date2025-01-16
Product CodeQGL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ADDNOX (BPSPM1) is a medical device manufactured by Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2025-01-16 under approval number K243289. 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 ADDNOX (BPSPM1)?

ADDNOX (BPSPM1) is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Nu Eyne Co., Ltd.. The 510(k) number is K243289.

When was ADDNOX (BPSPM1) approved by the FDA?

ADDNOX (BPSPM1) received FDA 510(k) clearance on 2025-01-16, under approval number K243289.

What company makes ADDNOX (BPSPM1)?

ADDNOX (BPSPM1) is manufactured by Nu Eyne Co., Ltd..

What is the FDA product code for ADDNOX (BPSPM1)?

The FDA product code for ADDNOX (BPSPM1) is QGL.

Other Devices by Nu Eyne Co., Ltd.

K192773ALLIVE K211380Elexir K213629SMILE K242719ELEXIR 2.0 (ALLIVE3)

Related Devices (Code: QGL)

DEN180041Monarch eTNS SystemNeurosigma, Inc. K213629SMILENu Eyne Co., Ltd. K232991BT-1000Bistos Co., Ltd. K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc.

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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