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FDA 510(k)

XCELLARISPRO TWIST 微針治療儀

K 號:K241790 · 2025-03-06

決定日期2025-03-06
產品代碼QAI
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

XCELLARISPRO TWIST microneedling device is the device name listed in this FDA 510(k) record. The listed applicant is Dermaroller GmbH. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K241790. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XCELLARISPRO TWIST microneedling device?

XCELLARISPRO TWIST microneedling device is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Dermaroller GmbH. The 510(k) number is K241790.

When did XCELLARISPRO TWIST microneedling device receive FDA 510(k) clearance?

XCELLARISPRO TWIST microneedling device received FDA 510(k) clearance on 2025-03-06, under 510(k) number K241790.

Who is the listed applicant for XCELLARISPRO TWIST microneedling device?

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

What is the FDA product code for XCELLARISPRO TWIST microneedling device?

The FDA product code for XCELLARISPRO TWIST microneedling device is QAI.

相關臨床試驗

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相關器械(代碼:QAI)

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。

官方來源

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