FDA 510(k)

IPL 髮毛去除器（DE03A-W、DE03A-P、DE03A-V、DE03A-G、DE03B-W、DE03B-P、DE03B-V、DE03B-G）

K 號：K243085 · 2024-12-21

申請人Zhuzhou Goldenhot Medical Technology Co., Ltd.

決定日期2024-12-21

產品代碼OHT

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

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-21 under 510(k) number K243085. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is a medical device that received FDA 510(k) clearance on 2024-12-21. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K243085.

When did IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) receive FDA 510(k) clearance?

IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) received FDA 510(k) clearance on 2024-12-21, under 510(k) number K243085.

Who is the listed applicant for IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

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

What is the FDA product code for IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)?

The FDA product code for IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) is OHT.

其他以 Zhuzhou Goldenhot Medical Technology Co., Ltd. 為申請人之記錄

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