Oniris; Oniris Plus
K-Number: K250353 · 2025-09-04
ApplicantOniris
Decision Date2025-09-04
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Oniris; Oniris Plus is a medical device manufactured by Oniris. It received FDA 510(k) clearance on 2025-09-04 under approval number K250353. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oniris; Oniris Plus?
Oniris; Oniris Plus is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Oniris. The 510(k) number is K250353.
When was Oniris; Oniris Plus approved by the FDA?
Oniris; Oniris Plus received FDA 510(k) clearance on 2025-09-04, under approval number K250353.
What company makes Oniris; Oniris Plus?
Oniris; Oniris Plus is manufactured by Oniris.
What is the FDA product code for Oniris; Oniris Plus?
The FDA product code for Oniris; Oniris Plus is LRK.
Related Devices (Code: LRK)
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.