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 a medical device manufactured by Nu Eyne Co., Ltd.. It received FDA 510(k) clearance on 2024-11-06 under approval 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. It is manufactured by Nu Eyne Co., Ltd.. The 510(k) number is K242719.
When was ELEXIR 2.0 (ALLIVE3) approved by the FDA?
ELEXIR 2.0 (ALLIVE3) received FDA 510(k) clearance on 2024-11-06, under approval number K242719.
What company makes ELEXIR 2.0 (ALLIVE3)?
ELEXIR 2.0 (ALLIVE3) is manufactured by Nu Eyne Co., Ltd..
What is the FDA product code for ELEXIR 2.0 (ALLIVE3)?
The FDA product code for ELEXIR 2.0 (ALLIVE3) is PCC.
Other Devices by Nu Eyne Co., Ltd.
Related Devices (Code: PCC)
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.