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FDA 510(k)

Diode Laser Hair Removal System

K-Number: K241860 · 2024-09-25

ApplicantBeijing Winkonlaser Technology Limited
Decision Date2024-09-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal System is a medical device manufactured by Beijing Winkonlaser Technology Limited. It received FDA 510(k) clearance on 2024-09-25 under approval number K241860. 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 Hair Removal System?

Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2024-09-25. It is manufactured by Beijing Winkonlaser Technology Limited. The 510(k) number is K241860.

When was Diode Laser Hair Removal System approved by the FDA?

Diode Laser Hair Removal System received FDA 510(k) clearance on 2024-09-25, under approval number K241860.

What company makes Diode Laser Hair Removal System?

Diode Laser Hair Removal System is manufactured by Beijing Winkonlaser Technology Limited.

What is the FDA product code for Diode Laser Hair Removal System?

The FDA product code for Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.

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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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