FDA 510(k)

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

Número K: K241057 · 2025-01-24

RequerenteWuhan Guangdun Technology Co.,Ltd..

Data da decisão2025-01-24

Código do produtoNHN

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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