FDA 510(k)

V-Laser

K-Number: K221427 · 2022-08-24

Decision Date2022-08-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

V-Laser is a medical device manufactured by Wontech Co., Ltd.. It received FDA 510(k) clearance on 2022-08-24 under approval number K221427. 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 V-Laser?

V-Laser is a medical device that received FDA 510(k) clearance on 2022-08-24. It is manufactured by Wontech Co., Ltd.. The 510(k) number is K221427.

When was V-Laser approved by the FDA?

V-Laser received FDA 510(k) clearance on 2022-08-24, under approval number K221427.

What company makes V-Laser?

V-Laser is manufactured by Wontech Co., Ltd..

What is the FDA product code for V-Laser?

The FDA product code for V-Laser 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.