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FDA 510(k)

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

K-Number: K241057 · 2025-01-24

ApplicantWuhan Guangdun Technology Co.,Ltd..
Decision Date2025-01-24
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: NHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia CorporationK212189FibroLuxMulti Radiance Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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