SIRONA 100治療雷射系統（OEM型號EVANLAS）
K 號：K231997 · 2024-10-15
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器材摘要
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is the device name listed in this FDA 510(k) record. The listed applicant is Cure Point Therapeutics, Inc.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K231997. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Cure Point Therapeutics, Inc.. The 510(k) number is K231997.
When did SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) receive FDA 510(k) clearance?
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) received FDA 510(k) clearance on 2024-10-15, under 510(k) number K231997.
Who is the listed applicant for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?
The FDA 510(k) record lists Cure Point Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?
The FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is ILY.
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相關器械（代碼：ILY）
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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