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FDA 510(k)

Erchonia Violet ZERONA® Z6 OTC

K-Number: K231474 · 2023-07-21

ApplicantErchonia Corporation
Decision Date2023-07-21
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erchonia Violet ZERONA® Z6 OTC is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K231474. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Erchonia Violet ZERONA® Z6 OTC?

Erchonia Violet ZERONA® Z6 OTC is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Erchonia Corporation. The 510(k) number is K231474.

When did Erchonia Violet ZERONA® Z6 OTC receive FDA 510(k) clearance?

Erchonia Violet ZERONA® Z6 OTC received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231474.

Who is the listed applicant for Erchonia Violet ZERONA® Z6 OTC?

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 Violet ZERONA® Z6 OTC?

The FDA product code for Erchonia Violet ZERONA® Z6 OTC is OLI.

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-405K221987Erchonia GVL

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Related Devices (Code: OLI)

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.

K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.K243854Contour Light (CL-100)Contour Research, LLCK252574Erchonia CLX (Model # CFL)Erchonia CorporationK252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.K243811Erchonia Zerona® VZ8Erchonia 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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