FDA 510(k)

SER Pen Carain 微系統 (MP1209SP)

K 號：K253153 · 2025-10-29

決定日期2025-10-29

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

SER Pen Carain MicroSystem (MP1209SP) is the device name listed in this FDA 510(k) record. The listed applicant is Su-Ko Technologies, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K253153. 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 SER Pen Carain MicroSystem (MP1209SP)?

SER Pen Carain MicroSystem (MP1209SP) is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Su-Ko Technologies, LLC. The 510(k) number is K253153.

When did SER Pen Carain MicroSystem (MP1209SP) receive FDA 510(k) clearance?

SER Pen Carain MicroSystem (MP1209SP) received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253153.

Who is the listed applicant for SER Pen Carain MicroSystem (MP1209SP)?

The FDA 510(k) record lists Su-Ko Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SER Pen Carain MicroSystem (MP1209SP)?

The FDA product code for SER Pen Carain MicroSystem (MP1209SP) is QAI.

其他以 Su-Ko Technologies, LLC 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。

K241355SER Pen Carain 微系統 (MP1209SP)

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.K252752艾拉可爾系統搭配微孔技術Cytrellis Biosystems, Inc.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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