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FDA 510(k)

基於光學的除毛設備

K 號：K180383 · 2018-05-11

申請人Shenzhen Gsd Tech Co., Ltd.
決定日期2018-05-11
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

Light based hair removal device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K180383. 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 Light based hair removal device?

Light based hair removal device is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K180383.

When did Light based hair removal device receive FDA 510(k) clearance?

Light based hair removal device received FDA 510(k) clearance on 2018-05-11, under 510(k) number K180383.

Who is the listed applicant for Light based hair removal device?

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

What is the FDA product code for Light based hair removal device?

The FDA product code for Light based hair removal device is OHT.

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其他以 Shenzhen Gsd Tech Co., Ltd. 為申請人之記錄

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