Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ETCHONIA ZERONA ARMS

K-Number: K121690 · 2012-08-23

ApplicantErchonia Corporation
Decision Date2012-08-23
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETCHONIA ZERONA ARMS is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2012-08-23 under 510(k) number K121690. 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 ETCHONIA ZERONA ARMS?

ETCHONIA ZERONA ARMS is a medical device that received FDA 510(k) clearance on 2012-08-23. The listed applicant is Erchonia Corporation. The 510(k) number is K121690.

When did ETCHONIA ZERONA ARMS receive FDA 510(k) clearance?

ETCHONIA ZERONA ARMS received FDA 510(k) clearance on 2012-08-23, under 510(k) number K121690.

Who is the listed applicant for ETCHONIA ZERONA ARMS?

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 ETCHONIA ZERONA ARMS?

The FDA product code for ETCHONIA ZERONA ARMS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 22 devices →

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.

↑