FDA 510(k)

美麗雅皮膚治療系統

K 號：K223871 · 2023-06-22

決定日期2023-06-22

產品代碼ONG

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

Miria Skin Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is AVAVA, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K223871. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Miria Skin Treatment System?

Miria Skin Treatment System is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is AVAVA, Inc.. The 510(k) number is K223871.

When did Miria Skin Treatment System receive FDA 510(k) clearance?

Miria Skin Treatment System received FDA 510(k) clearance on 2023-06-22, under 510(k) number K223871.

Who is the listed applicant for Miria Skin Treatment System?

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

What is the FDA product code for Miria Skin Treatment System?

The FDA product code for Miria Skin Treatment System is ONG.

其他以 AVAVA, 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。

K252155AVAVA™ 皮膚治療系統 K250402AVAVA™ 皮膚治療系統 K221268SR-1皮膚治療系統 K213726PL-1 皮膚治療系統 K202884SR-1皮膚治療系統

相關器械（代碼：ONG）

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。

K252155AVAVA™ 皮膚治療系統AVAVA, Inc.K244060eCO2 3DLutronic Corporation K251031纖維雷射治療系統（HS-232，HS-233）Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ 皮膚治療系統AVAVA, Inc.K233550MOSAIC 3D（外科雷射）Lutronic Aesthetic K221268SR-1皮膚治療系統AVAVA, Inc.

官方來源

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