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FDA 510(k)

NeoSculpt Plus

K 號:K252888 · 2026-03-09

決定日期2026-03-09
產品代碼PBX
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

NeoSculpt Plus is the device name listed in this FDA 510(k) record. The listed applicant is S&M Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K252888. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeoSculpt Plus?

NeoSculpt Plus is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is S&M Medical Co., Ltd.. The 510(k) number is K252888.

When did NeoSculpt Plus receive FDA 510(k) clearance?

NeoSculpt Plus received FDA 510(k) clearance on 2026-03-09, under 510(k) number K252888.

Who is the listed applicant for NeoSculpt Plus?

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

What is the FDA product code for NeoSculpt Plus?

The FDA product code for NeoSculpt Plus is PBX.

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。

相關器械(代碼:PBX)

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。

官方來源

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