FDA 510(k)

Oniris；Oniris Plus

K 號：K250353 · 2025-09-04

申請人Oniris

決定日期2025-09-04

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Oniris; Oniris Plus is the device name listed in this FDA 510(k) record. The listed applicant is Oniris. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250353. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oniris; Oniris Plus?

Oniris; Oniris Plus is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Oniris. The 510(k) number is K250353.

When did Oniris; Oniris Plus receive FDA 510(k) clearance?

Oniris; Oniris Plus received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250353.

Who is the listed applicant for Oniris; Oniris Plus?

The FDA 510(k) record lists Oniris as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oniris; Oniris Plus?

The FDA product code for Oniris; Oniris Plus is LRK.

相關器械（代碼：LRK）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LRK）

官方來源