FDA 510(k)

斯麥麗歐正畸器

K 號：K260788 · 2026-05-08

決定日期2026-05-08

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Smylio Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Smylio, Inc.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K260788. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smylio Aligners?

Smylio Aligners is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Smylio, Inc.. The 510(k) number is K260788.

When did Smylio Aligners receive FDA 510(k) clearance?

Smylio Aligners received FDA 510(k) clearance on 2026-05-08, under 510(k) number K260788.

Who is the listed applicant for Smylio Aligners?

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

What is the FDA product code for Smylio Aligners?

The FDA product code for Smylio Aligners is NXC.

其他以 Smylio, Inc. 為申請人之記錄

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相關器械（代碼：NXC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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