Vbeam Prima 激光系統
K 號：K183452 · 2019-02-01
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器材摘要
Vbeam Prima Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corp.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K183452. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Vbeam Prima Laser System?
Vbeam Prima Laser System is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Candela Corp.. The 510(k) number is K183452.
When did Vbeam Prima Laser System receive FDA 510(k) clearance?
Vbeam Prima Laser System received FDA 510(k) clearance on 2019-02-01, under 510(k) number K183452.
Who is the listed applicant for Vbeam Prima Laser System?
The FDA 510(k) record lists Candela Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vbeam Prima Laser System?
The FDA product code for Vbeam Prima Laser System is GEX. This falls under the Gastroenterology category.
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相關器械（代碼：GEX）
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。
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官方來源
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