FDA 510(k)

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

Numéro K : K241057 · 2025-01-24

DemandeurWuhan Guangdun Technology Co.,Ltd..

Date de décision2025-01-24

Code produitNHN

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : NHN)

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation K212189FibroLuxMulti Radiance Medical

Source officielle

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