FDA 510(k)

ID-500 iRestore 髮絲生長系統

K 號：K213094 · 2021-12-22

決定日期2021-12-22

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

ID-500 iRestore Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213094. 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 ID-500 iRestore Hair Growth System?

ID-500 iRestore Hair Growth System is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K213094.

When did ID-500 iRestore Hair Growth System receive FDA 510(k) clearance?

ID-500 iRestore Hair Growth System received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213094.

Who is the listed applicant for ID-500 iRestore Hair Growth System?

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

What is the FDA product code for ID-500 iRestore Hair Growth System?

The FDA product code for ID-500 iRestore Hair Growth System is OAP.

其他以 Freedom Laser Therapy, 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。

K222081ID-510 iRestore Elite K183417iRestore Professional 282 K151662iRestore

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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官方來源

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