FDA 510(k)

NaturaLase CO2 Laser System

K-Number: K152529 · 2016-02-04

Decision Date2016-02-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NaturaLase CO2 Laser System is a medical device manufactured by Focus Medical, LLC. It received FDA 510(k) clearance on 2016-02-04 under approval number K152529. 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 NaturaLase CO2 Laser System?

NaturaLase CO2 Laser System is a medical device that received FDA 510(k) clearance on 2016-02-04. It is manufactured by Focus Medical, LLC. The 510(k) number is K152529.

When was NaturaLase CO2 Laser System approved by the FDA?

NaturaLase CO2 Laser System received FDA 510(k) clearance on 2016-02-04, under approval number K152529.

What company makes NaturaLase CO2 Laser System?

NaturaLase CO2 Laser System is manufactured by Focus Medical, LLC.

What is the FDA product code for NaturaLase CO2 Laser System?

The FDA product code for NaturaLase CO2 Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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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.