FDA 510(k)

德米專業版

K 號：K253461 · 2025-10-14

決定日期2025-10-14

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

Demi Pro is the device name listed in this FDA 510(k) record. The listed applicant is Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K253461. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Demi Pro?

Demi Pro is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Meta Systems Co., Ltd.. The 510(k) number is K253461.

When did Demi Pro receive FDA 510(k) clearance?

Demi Pro received FDA 510(k) clearance on 2025-10-14, under 510(k) number K253461.

Who is the listed applicant for Demi Pro?

The FDA 510(k) record lists Meta Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Demi Pro?

The FDA product code for Demi Pro is EBZ.

其他以 Meta Systems Co., Ltd. 為申請人之記錄

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。

K210475EQ-M K210789EQ-PEX K153285EMS-200

相關器械（代碼：EBZ）

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。

K253131治療光源（M-Cure 6）Guangzhou Rebornendo Medical Instrument Co., Ltd.K242386藍月Genoss Co., Ltd.K243921LED固化燈（DB686 HALO）Foshan Coxo Medical Instrument Co., Ltd.K250009LED固化燈（C01-X，C02-X）Premium Plus (Dongguan) Limited K241238LOOP™ LED 紫外線固化燈系統 (CLK01)Garrison Dental Solutions, LLC K223414治療光，型號：MaxCure 9Guilin Refine Medical Instrument Co., Ltd.

官方來源

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