FDA 510(k)

UltraClear Fractional Laser System

K-Number: K210847 · 2021-12-10

Decision Date2021-12-10

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UltraClear Fractional Laser System is a medical device manufactured by Fa International, LP. It received FDA 510(k) clearance on 2021-12-10 under approval number K210847. 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 UltraClear Fractional Laser System?

UltraClear Fractional Laser System is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Fa International, LP. The 510(k) number is K210847.

When was UltraClear Fractional Laser System approved by the FDA?

UltraClear Fractional Laser System received FDA 510(k) clearance on 2021-12-10, under approval number K210847.

What company makes UltraClear Fractional Laser System?

UltraClear Fractional Laser System is manufactured by Fa International, LP.

What is the FDA product code for UltraClear Fractional Laser System?

The FDA product code for UltraClear Fractional Laser 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.