FDA 510(k)

Avéli

K 號：K221336 · 2022-08-05

決定日期2022-08-05

產品代碼OUP

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

Avéli is the device name listed in this FDA 510(k) record. The listed applicant is Revelle Aesthetics, Inc.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K221336. The device is classified under product code OUP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avéli?

Avéli is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Revelle Aesthetics, Inc.. The 510(k) number is K221336.

When did Avéli receive FDA 510(k) clearance?

Avéli received FDA 510(k) clearance on 2022-08-05, under 510(k) number K221336.

Who is the listed applicant for Avéli?

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

What is the FDA product code for Avéli?

The FDA product code for Avéli is OUP.

其他以 Revelle Aesthetics, 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。

K232153Avéli

相關器械（代碼：OUP）

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。

K232153AvéliRevelle Aesthetics, Inc.K212399AveliNc8, Inc.K192185Cellfina 系統Ulthera, Inc.K161885Cellfina 系統Ulthera, Inc.K153677Cellfina 系統Ulthera, Inc.

官方來源

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