FDA 510(k)

VARIOS 170 LUX 計量系統 (VA170LUXS10)；VARIOS 170 LUX 計量系統 (VA170LUXS11)；VARIOS 170 計量系統 (VA170S11)

K 號：K251689 · 2025-09-19

決定日期2025-09-19

產品代碼ELC

諮詢委員會DE

決定相當於

器材摘要

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K251689. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Nakanishi, Inc.. The 510(k) number is K251689.

When did VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) receive FDA 510(k) clearance?

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K251689.

Who is the listed applicant for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

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

What is the FDA product code for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

The FDA product code for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is ELC.

其他以 Nakanishi, Inc. 為申請人之記錄

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相關器械（代碼：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT機器空氣流預防主機E.M.S Electro Medical Systems S.A K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AG K240707超聲刮牙器（WD-JY-B002、WD-JY-W001、WD-JY-R003、WD-JY-G004、WD-JY-B003、WD-JY-C006、WD-JY-M0014、WD-JY-N0015、WD-JY-N0016、WD-JY-N0017、WD-JY-E007、WD-JY-F008、WD-JY-A005、WD-JY-H009、WD-JY-I0011、WD-JY-K0012、WD-JY-K0013、WD-JY-K0014、WD-JY-L0013、WD-JY-L0014、WD-JY-L0015、WD-JY-L0016、WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.K240801BioSonic US200 超聲波刮牙器 (60034537)Dent4you AG

官方來源

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