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FDA 510(k)

ELEXIR 2.0 (ALLIVE3)

K-Number: K242719 · 2024-11-06

ApplicantNu Eyne Co., Ltd.
Decision Date2024-11-06
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEXIR 2.0 (ALLIVE3) 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 2024-11-06 under 510(k) number K242719. 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 2.0 (ALLIVE3)?

ELEXIR 2.0 (ALLIVE3) is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Nu Eyne Co., Ltd.. The 510(k) number is K242719.

When did ELEXIR 2.0 (ALLIVE3) receive FDA 510(k) clearance?

ELEXIR 2.0 (ALLIVE3) received FDA 510(k) clearance on 2024-11-06, under 510(k) number K242719.

Who is the listed applicant for ELEXIR 2.0 (ALLIVE3)?

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 2.0 (ALLIVE3)?

The FDA product code for ELEXIR 2.0 (ALLIVE3) is PCC.

Related Clinical Trials

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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)K213629SMILEK211380ElexirK192773ALLIVE

Related Devices (Code: PCC)

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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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