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FDA 510(k)

NAVILAS Laser System

K-Number: K162191 · 2016-11-22

ApplicantOd-Os GmbH
Decision Date2016-11-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NAVILAS Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Od-Os GmbH. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162191. 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 NAVILAS Laser System?

NAVILAS Laser System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Od-Os GmbH. The 510(k) number is K162191.

When did NAVILAS Laser System receive FDA 510(k) clearance?

NAVILAS Laser System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162191.

Who is the listed applicant for NAVILAS Laser System?

The FDA 510(k) record lists Od-Os GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVILAS Laser System?

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

Related Clinical Trials

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.

NCT07607496MacuTherm Performance Study in Patients With iAMDRECRUITING

Other records listing Od-Os GmbH as applicant

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.

K251772Navilas Laser System 577sl (156691)

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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