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FDA 510(k)

Diode Laser Therapy Device (DF-DIODE LASER-S1)

K-Number: K241547 · 2024-08-13

ApplicantWeifang Dragonfly Electronics Technology Co., Ltd.
Decision Date2024-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Therapy Device (DF-DIODE LASER-S1) is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241547. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diode Laser Therapy Device (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. The 510(k) number is K241547.

When did Diode Laser Therapy Device (DF-DIODE LASER-S1) receive FDA 510(k) clearance?

Diode Laser Therapy Device (DF-DIODE LASER-S1) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241547.

Who is the listed applicant for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

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

What is the FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1) is GEX. This falls under the Gastroenterology category.

Related Devices (Code: GEX)

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.

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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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