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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 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 2025-01-16 under 510(k) 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. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K243289.

When did ADDNOX (BPSPM1) receive FDA 510(k) clearance?

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

Who is the listed applicant for ADDNOX (BPSPM1)?

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 ADDNOX (BPSPM1)?

The FDA product code for ADDNOX (BPSPM1) 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.

K242719ELEXIR 2.0 (ALLIVE3)K213629SMILEK211380ElexirK192773ALLIVE

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.

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