FDA 510(k)

皮膚筆SteriLock微系統（MP1209SL）

K 號：K253002 · 2026-02-19

決定日期2026-02-19

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

SkinStylus SteriLock MicroSystem (MP1209SL) is the device name listed in this FDA 510(k) record. The listed applicant is Esthetic Medical, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K253002. 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 SkinStylus SteriLock MicroSystem (MP1209SL)?

SkinStylus SteriLock MicroSystem (MP1209SL) is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Esthetic Medical, Inc.. The 510(k) number is K253002.

When did SkinStylus SteriLock MicroSystem (MP1209SL) receive FDA 510(k) clearance?

SkinStylus SteriLock MicroSystem (MP1209SL) received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253002.

Who is the listed applicant for SkinStylus SteriLock MicroSystem (MP1209SL)?

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

What is the FDA product code for SkinStylus SteriLock MicroSystem (MP1209SL)?

The FDA product code for SkinStylus SteriLock MicroSystem (MP1209SL) is QAI.

其他以 Esthetic Medical, 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。

K231073SkinStylus SteriLock® 微系統，型號編號 MP1209SL

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