FDA 510(k)

牙科二極雷射，SOGA雷射，ILaser II

K 號：K211150 · 2022-07-01

決定日期2022-07-01

產品代碼NVK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Dental diode laser, SOGA Laser, ILaser II is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Soga Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K211150. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental diode laser, SOGA Laser, ILaser II?

Dental diode laser, SOGA Laser, ILaser II is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Shenzhen Soga Technology Co., Ltd.. The 510(k) number is K211150.

When did Dental diode laser, SOGA Laser, ILaser II receive FDA 510(k) clearance?

Dental diode laser, SOGA Laser, ILaser II received FDA 510(k) clearance on 2022-07-01, under 510(k) number K211150.

Who is the listed applicant for Dental diode laser, SOGA Laser, ILaser II?

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

What is the FDA product code for Dental diode laser, SOGA Laser, ILaser II?

The FDA product code for Dental diode laser, SOGA Laser, ILaser II is NVK.

其他以 Shenzhen Soga Technology 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。

K253309SOGA雷射治療系統家族的Aurora手持式工具系列（Aurora-S）；SOGA雷射治療系統家族的牙科二極雷射（ILaser III Pro）K214008牙科二極雷射

相關器械（代碼：NVK）

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。

K253309SOGA雷射治療系統家族的Aurora手持式工具系列（Aurora-S）；SOGA雷射治療系統家族的牙科二極雷射（ILaser III Pro）Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 轟軟組織雷射Azena Medical, LLC K250731MateLaser醫療二極雷射系統（ML-DLS-30）Matelaser, Inc.K243764醫用二極雷射儀（UTU3-F7B、UTU3-F7W、UTU3-G7B、UTU3-G7W、UTU-G20B、UTU-G20W）Wuhan Pioon Technology Co., Ltd.K230047醫用二極雷射系統Gigaalaser Company , Ltd.K232885Dawn二極管雷射系統Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

官方來源

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