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FDA 510(k)

Erchonia FX-635

K-Number: K190572 · 2019-06-01

ApplicantErchonia Corporation
Decision Date2019-06-01
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 2019-06-01 under approval number K190572. 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 2019-06-01. It is manufactured by Erchonia Corporation. The 510(k) number is K190572.

When was Erchonia FX-635 approved by the FDA?

Erchonia FX-635 received FDA 510(k) clearance on 2019-06-01, under approval number K190572.

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

NCT07600203 A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ RECRUITING NCT06656325 An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis RECRUITING

Other Devices by Erchonia Corporation

K162578Zerona Z6 OTC K152196Erchonia EVRL K153052Erchonia PL Touch K180197Erchonia FX-635 K191257Erchonia EVRL K192544Erchonia Emerald

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Related Devices (Code: NHN)

K162022Collagentex Rx-1Tanses Technologies, Inc. K152196Erchonia EVRLErchonia Corporation K153052Erchonia PL TouchErchonia Corporation K180197Erchonia FX-635Erchonia Corporation K180585Collagentex Rx-6Tanses Technologies, Inc. K171354MR4 LaserMulti Radiance Medical

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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