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

FDA 510(k)

MIRARI® Cold Plasma System ( GV-M2-01)

K-Number: K242553 · 2024-11-21

ApplicantGeneral Vibronics, Inc.
Decision Date2024-11-21
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIRARI® Cold Plasma System ( GV-M2-01) is a medical device manufactured by General Vibronics, Inc.. It received FDA 510(k) clearance on 2024-11-21 under approval number K242553. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRARI® Cold Plasma System ( GV-M2-01)?

MIRARI® Cold Plasma System ( GV-M2-01) is a medical device that received FDA 510(k) clearance on 2024-11-21. It is manufactured by General Vibronics, Inc.. The 510(k) number is K242553.

When was MIRARI® Cold Plasma System ( GV-M2-01) approved by the FDA?

MIRARI® Cold Plasma System ( GV-M2-01) received FDA 510(k) clearance on 2024-11-21, under approval number K242553.

What company makes MIRARI® Cold Plasma System ( GV-M2-01)?

MIRARI® Cold Plasma System ( GV-M2-01) is manufactured by General Vibronics, Inc..

What is the FDA product code for MIRARI® Cold Plasma System ( GV-M2-01)?

The FDA product code for MIRARI® Cold Plasma System ( GV-M2-01) is PBX.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT06328647 Quantra Point-of-Care Hemostasis Monitoring ACTIVE_NOT_RECRUITING NCT07563309 A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test RECRUITING NCT06562803 Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis RECRUITING NCT07139808 Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

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.

↑