GENERAL VIBRONICS, INC.

FDA Device Registration & Listing · Tempe, AZ, US · Registration 3013652305

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013652305
FEI Number
3013652305
Entity Name
GENERAL VIBRONICS, INC.
City/State/Country
Tempe, AZ, US
Establishment Address
1615 E Warner Rd Ste 4, Tempe, AZ 85284, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
General Vibronics, Inc. (Owner Number: 10092586)
Owner / Operator Contact Address
1615 E. Warner Road, Suite 4, Tempe, AZ 85284, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242553
PMA Number
N/A

All Registered Proprietary Names

MIRARI Cold Plasma System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2025-01-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-23

Official Correspondent

Huan Truong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

General Vibronics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013652305. Last updated year: 2026. Please use registration number 3013652305 when referencing this establishment in official correspondence.
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