FDA 510(k)

雷射頭髮生長設備（F21151、F21152、F21153、F21154、F21155、F21156、F21157、F21158、F21159）

K 號：K260899 · 2026-06-16

決定日期2026-06-16

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is the device name listed in this FDA 510(k) record. The listed applicant is Zdeer Technology (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K260899. 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 Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Zdeer Technology (Henan) Co., Ltd.. The 510(k) number is K260899.

When did Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) receive FDA 510(k) clearance?

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260899.

Who is the listed applicant for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

The FDA 510(k) record lists Zdeer Technology (Henan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

The FDA product code for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is OAP.

其他以 Zdeer Technology (Henan) Co., Ltd. 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。

K260452骨導聽力輔助設備（G41157、G41158、G41159、G41160、G42151、G42152、G42153、G42154、G42155、G42156、G42157、G42158、G42159、G42160、G43151、G43152、G43153、G43154、G43155、G43156、G45151、G45152、G45153、G45154、G45155、G45156、G45157、G45158、G45159、G45160、G46151、G46152、G46153、G46154、G46155、G46156、G46157、G46158）

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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