FDA 510(k)

HIGHERDOSE Body Sculptor（型號：GS-03）

K 號：K252603 · 2026-01-28

申請人Shenzhen Kaiyan Medical Equipment Co., Ltd.

決定日期2026-01-28

產品代碼OHS

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

HIGHERDOSE Body Sculptor (Model: GS-03) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K252603. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HIGHERDOSE Body Sculptor (Model: GS-03)?

HIGHERDOSE Body Sculptor (Model: GS-03) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252603.

When did HIGHERDOSE Body Sculptor (Model: GS-03) receive FDA 510(k) clearance?

HIGHERDOSE Body Sculptor (Model: GS-03) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K252603.

Who is the listed applicant for HIGHERDOSE Body Sculptor (Model: GS-03)?

FDA 510(k) 記錄將深圳凱亞醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for HIGHERDOSE Body Sculptor (Model: GS-03)?

The FDA product code for HIGHERDOSE Body Sculptor (Model: GS-03) is OHS.

其他以 Shenzhen Kaiyan Medical Equipment 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。

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相關器械（代碼：OHS）

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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