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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 the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) 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. The listed applicant is Erchonia Corporation. The 510(k) number is K180197.

When did Erchonia FX-635 receive FDA 510(k) clearance?

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

Who is the listed applicant for Erchonia FX-635?

The FDA 510(k) record lists Erchonia Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

NCT06656325An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of PeriodontitisRECRUITINGNCT06941610An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin LaxityTERMINATEDNCT07121933Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of PainCOMPLETEDNCT07600203A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJRECRUITING

Other records listing Erchonia Corporation 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.

K251903Erchonia DPN Laser (Model# EVRL)K252574Erchonia CLX (Model # CFL)K251843Erchonia EVRLK243811Erchonia Zerona® VZ8K231409Erchonia FX-405K231474Erchonia Violet ZERONA® Z6 OTC

View all 17 devices →

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia 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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