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FDA 510(k)

Diode laser Treatment System (K18)

K-Number: K241498 · 2024-11-18

ApplicantHebei Keylaser Sci-Tech Co.,Ltd
Decision Date2024-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser Treatment System (K18) is a medical device manufactured by Hebei Keylaser Sci-Tech Co.,Ltd. It received FDA 510(k) clearance on 2024-11-18 under approval number K241498. 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 Treatment System (K18)?

Diode laser Treatment System (K18) is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Hebei Keylaser Sci-Tech Co.,Ltd. The 510(k) number is K241498.

When was Diode laser Treatment System (K18) approved by the FDA?

Diode laser Treatment System (K18) received FDA 510(k) clearance on 2024-11-18, under approval number K241498.

What company makes Diode laser Treatment System (K18)?

Diode laser Treatment System (K18) is manufactured by Hebei Keylaser Sci-Tech Co.,Ltd.

What is the FDA product code for Diode laser Treatment System (K18)?

The FDA product code for Diode laser Treatment System (K18) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Other Devices by Hebei Keylaser Sci-Tech Co.,Ltd

K252519CO2 Laser Therapy System (K106) K252515Q-Switched Nd:Yag laser (K690)

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Official Source

View on FDA Database →

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

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