FDA 510(k)

LightForce 歸正系統 (LFO 系統)

K 號：K200148 · 2020-02-21

決定日期2020-02-21

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

LightForce Orthodontic System (LFO System) is the device name listed in this FDA 510(k) record. The listed applicant is Lightforce Orthodontics. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K200148. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LightForce Orthodontic System (LFO System)?

LightForce Orthodontic System (LFO System) is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Lightforce Orthodontics. The 510(k) number is K200148.

When did LightForce Orthodontic System (LFO System) receive FDA 510(k) clearance?

LightForce Orthodontic System (LFO System) received FDA 510(k) clearance on 2020-02-21, under 510(k) number K200148.

Who is the listed applicant for LightForce Orthodontic System (LFO System)?

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

What is the FDA product code for LightForce Orthodontic System (LFO System)?

The FDA product code for LightForce Orthodontic System (LFO System) is NJM.

其他以 Lightforce Orthodontics 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。

K232827LightForce 歸正系統 K222764LightForce 歸正系統

相關器械（代碼：NJM）

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。

K232827LightForce 歸正系統Lightforce Orthodontics K232011CleoAmerican Orthodontics K231635A-Line 高級Biocetec Co., Ltd.K230225DynaFlex 清晰牙弓絲與按鈕Dyna Flex K222847陶瓷牙弓絲正畸器Orthometric - Industria E Comercio DE Produtos Medicos K222764LightForce 歸正系統Lightforce Orthodontics

官方來源

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