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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 the device name listed in this FDA 510(k) record. The listed applicant is Novian Health, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) 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. The listed applicant is Novian Health, Inc.. The 510(k) number is K160392.

When did Novilase Laser Therapy System, Model LTS-2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Novilase Laser Therapy System, Model LTS-2?

The FDA 510(k) record lists Novian Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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