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FDA 510(k)

Novilase Laser Therapy System, Model LTS-2

K-Number: K160392 · 2016-02-26

ApplicantNovian Health, Inc.
Decision Date2016-02-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Novilase Laser Therapy System, Model LTS-2 is a medical device manufactured by Novian Health, Inc.. It received FDA 510(k) clearance on 2016-02-26 under approval number K160392. 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 Novilase Laser Therapy System, Model LTS-2?

Novilase Laser Therapy System, Model LTS-2 is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Novian Health, Inc.. The 510(k) number is K160392.

When was Novilase Laser Therapy System, Model LTS-2 approved by the FDA?

Novilase Laser Therapy System, Model LTS-2 received FDA 510(k) clearance on 2016-02-26, under approval number K160392.

What company makes Novilase Laser Therapy System, Model LTS-2?

Novilase Laser Therapy System, Model LTS-2 is manufactured by Novian Health, Inc..

What is the FDA product code for Novilase Laser Therapy System, Model LTS-2?

The FDA product code for Novilase Laser Therapy System, Model LTS-2 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.

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