FDA 510(k)

強化手持式疼痛緩解雷射儀器（GD-P-E）

K 號：K241057 · 2025-01-24

決定日期2025-01-24

產品代碼NHN

諮詢委員會PM

決定相當於

器材摘要

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Guangdun Technology Co.,Ltd... It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241057. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)?

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Wuhan Guangdun Technology Co.,Ltd... The 510(k) number is K241057.

When did Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) receive FDA 510(k) clearance?

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241057.

Who is the listed applicant for Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)?

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

What is the FDA product code for Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)?

The FDA product code for Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) is NHN.

相關器械（代碼：NHN）

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K254024MR5 活動專業版Multi Radiance Medical, Inc.K251903Erchonia DPN雷射（型號# EVRL）Erchonia Corporation K252273治療美國Dmc Importação E Exportação DE Equipamentos Ltda K232813治療EC，治療XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation K212189維布羅盧克斯Multi Radiance Medical

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NHN）

官方來源