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FDA 510(k)

Erchonia FX-635

K-Number: K180197 · 2018-05-21

ApplicantErchonia Corporation
Decision Date2018-05-21
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Erchonia FX-635 is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2018-05-21 under approval number K180197. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Erchonia FX-635?

Erchonia FX-635 is a medical device that received FDA 510(k) clearance on 2018-05-21. It is manufactured by Erchonia Corporation. The 510(k) number is K180197.

When was Erchonia FX-635 approved by the FDA?

Erchonia FX-635 received FDA 510(k) clearance on 2018-05-21, under approval number K180197.

What company makes Erchonia FX-635?

Erchonia FX-635 is manufactured by Erchonia Corporation.

What is the FDA product code for Erchonia FX-635?

The FDA product code for Erchonia FX-635 is NHN.

Related Clinical Trials

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Other Devices by Erchonia Corporation

K162578Zerona Z6 OTC K152196Erchonia EVRL K153052Erchonia PL Touch K191257Erchonia EVRL K190572Erchonia FX-635 K192544Erchonia Emerald

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Related Devices (Code: NHN)

K162022Collagentex Rx-1Tanses Technologies, Inc. K152196Erchonia EVRLErchonia Corporation K153052Erchonia PL TouchErchonia Corporation K180585Collagentex Rx-6Tanses Technologies, Inc. K171354MR4 LaserMulti Radiance Medical K191257Erchonia EVRLErchonia Corporation

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.

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