DeviceClearance

MIRARI® Cold Plasma System ( GV-M2-01)— 510(k) K242553

Substantially Equivalent

General Vibronics, Inc.

FDA 510(k) clearance K242553 for MIRARI® Cold Plasma System ( GV-M2-01), Substantially Equivalent on 2024-11-21. Applicant: General Vibronics, Inc.. Device class: 2.

Clearance details

Applicant
General Vibronics, Inc.
Product code
Code PBX
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tempe, AZ, US
Download summary PDFView on FDA.gov ↗

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