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FDA 510(k)

紅波除毛器

K 號：K212099 · 2021-09-24

申請人Shenzhen Accompany Technology Co., Ltd.
決定日期2021-09-24
產品代碼ONF
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

Red Wave Hair Removal is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Accompany Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212099. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Red Wave Hair Removal?

Red Wave Hair Removal is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Shenzhen Accompany Technology Co., Ltd.. The 510(k) number is K212099.

When did Red Wave Hair Removal receive FDA 510(k) clearance?

Red Wave Hair Removal received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212099.

Who is the listed applicant for Red Wave Hair Removal?

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

What is the FDA product code for Red Wave Hair Removal?

The FDA product code for Red Wave Hair Removal is ONF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：ONF）

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。

K261204強烈脈衝光療法設備Sanhe LEFIS Electronics Co., Ltd.K251545強烈脈衝光療法設備（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952醫療設備名稱：MEDILIGHTMedicreations, LLCK243123IPL治療設備（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA 草莓El.En S.P.A.K242440強烈脈衝光治療系統（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.

官方來源

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