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FDA 510(k)

SOGA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）

K 號：K253309 · 2026-05-19

申請人Shenzhen Soga Technology Co., Ltd.
決定日期2026-05-19
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

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) 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 2026-05-19 under 510(k) number K253309. 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 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Shenzhen Soga Technology Co., Ltd.. The 510(k) number is K253309.

When did SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) receive FDA 510(k) clearance?

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) received FDA 510(k) clearance on 2026-05-19, under 510(k) number K253309.

Who is the listed applicant for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

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 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)?

The FDA product code for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) is NVK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K211150牙科二極雷射，SOGA雷射，ILaser IIK214008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。

K260765Gemini NOVA 810+980 轟軟組織雷射Azena Medical, LLCK250731MateLaser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.,LtdK232222Primo牙科雷射（Primo、Primo Komfort、Primo Lite、Primo Blue 及 Primo Triplo）Medency S.R.L.

官方來源

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