FDA 510(k)

艾拉可爾系統搭配微孔技術

K 號：K252752 · 2025-10-30

決定日期2025-10-30

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

ellacor System with Micro-Coring Technology is the device name listed in this FDA 510(k) record. The listed applicant is Cytrellis Biosystems, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252752. 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 ellacor System with Micro-Coring Technology?

ellacor System with Micro-Coring Technology is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Cytrellis Biosystems, Inc.. The 510(k) number is K252752.

When did ellacor System with Micro-Coring Technology receive FDA 510(k) clearance?

ellacor System with Micro-Coring Technology received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252752.

Who is the listed applicant for ellacor System with Micro-Coring Technology?

The FDA 510(k) record lists Cytrellis Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ellacor System with Micro-Coring Technology?

The FDA product code for ellacor System with Micro-Coring Technology is QAI.

其他以 Cytrellis Biosystems, Inc. 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。

K202517Cytrellis皮膚微釘系統

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。

K252591自動微針系統 (CODE-X)Woorhi Mechatronics Co., Ltd.K253002皮膚筆SteriLock微系統（MP1209SL）Esthetic Medical, Inc.K253153SER Pen Carain 微系統 (MP1209SP)Su-Ko Technologies, LLC K243800PRO Pen 微針治療系統（6883）Dermalogica, LLC K243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.K2434721NEED ProCampomats S.R.L.

官方來源

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