FDA 510(k)

Grivamax雷射系列，型號272及148

K 號：K211192 · 2021-07-20

決定日期2021-07-20

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Grivamax Family of Lasers, Models 272 and 148 is the device name listed in this FDA 510(k) record. The listed applicant is Leana Orders, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K211192. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Grivamax Family of Lasers, Models 272 and 148?

Grivamax Family of Lasers, Models 272 and 148 is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is Leana Orders, Inc.. The 510(k) number is K211192.

When did Grivamax Family of Lasers, Models 272 and 148 receive FDA 510(k) clearance?

Grivamax Family of Lasers, Models 272 and 148 received FDA 510(k) clearance on 2021-07-20, under 510(k) number K211192.

Who is the listed applicant for Grivamax Family of Lasers, Models 272 and 148?

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

What is the FDA product code for Grivamax Family of Lasers, Models 272 and 148?

The FDA product code for Grivamax Family of Lasers, Models 272 and 148 is OAP.

其他以 Leana Orders, 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。

K171895Grivamax 髮絲生長系統

相關器械（代碼：OAP）

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。

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