FDA 510(k)

AviClear Laser System

K-Number: K213461 · 2022-03-24

Decision Date2022-03-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AviClear Laser System is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2022-03-24 under approval number K213461. 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 AviClear Laser System?

AviClear Laser System is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Cutera, Inc.. The 510(k) number is K213461.

When was AviClear Laser System approved by the FDA?

AviClear Laser System received FDA 510(k) clearance on 2022-03-24, under approval number K213461.

What company makes AviClear Laser System?

AviClear Laser System is manufactured by Cutera, Inc..

What is the FDA product code for AviClear Laser System?

The FDA product code for AviClear Laser System 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.