FDA 510(k)

LightWalker Laser System Family

K-Number: K202985 · 2021-03-19

Decision Date2021-03-19

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LightWalker Laser System Family is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2021-03-19 under approval number K202985. 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 LightWalker Laser System Family?

LightWalker Laser System Family is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Fotona D.O.O.. The 510(k) number is K202985.

When was LightWalker Laser System Family approved by the FDA?

LightWalker Laser System Family received FDA 510(k) clearance on 2021-03-19, under approval number K202985.

What company makes LightWalker Laser System Family?

LightWalker Laser System Family is manufactured by Fotona D.O.O..

What is the FDA product code for LightWalker Laser System Family?

The FDA product code for LightWalker Laser System Family is GEX. This falls under the Gastroenterology category.

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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.