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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 the device name listed in this FDA 510(k) record. The listed applicant is General Vibronics, Inc.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) 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. The listed applicant is General Vibronics, Inc.. The 510(k) number is K242553.

When did MIRARI® Cold Plasma System ( GV-M2-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for MIRARI® Cold Plasma System ( GV-M2-01)?

The FDA 510(k) record lists General Vibronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: PBX)

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.

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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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