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FDA 510(k)

Erchonia GVL

K-Number: K221987 · 2022-09-01

ApplicantErchonia Corporation
Decision Date2022-09-01
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Erchonia GVL is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K221987. 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 GVL?

Erchonia GVL is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Erchonia Corporation. The 510(k) number is K221987.

When did Erchonia GVL receive FDA 510(k) clearance?

Erchonia GVL received FDA 510(k) clearance on 2022-09-01, under 510(k) number K221987.

Who is the listed applicant for Erchonia GVL?

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 GVL?

The FDA product code for Erchonia GVL 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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