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FDA 510(k)

Elexir

K-Number: K211380 · 2021-07-30

ApplicantNu Eyne Co., Ltd.
Decision Date2021-07-30
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Elexir 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 2021-07-30 under 510(k) number K211380. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elexir?

Elexir is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K211380.

When did Elexir receive FDA 510(k) clearance?

Elexir received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211380.

Who is the listed applicant for Elexir?

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 Elexir?

The FDA product code for Elexir is PCC.

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)K213629SMILEK192773ALLIVE

Related Devices (Code: PCC)

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.

K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, 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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