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FDA 510(k)

Multifrax Laser System

K-Number: K213332 · 2022-06-03

ApplicantParadigm Medical Corporation
Decision Date2022-06-03
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Multifrax Laser System is a medical device manufactured by Paradigm Medical Corporation. It received FDA 510(k) clearance on 2022-06-03 under approval number K213332. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multifrax Laser System?

Multifrax Laser System is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Paradigm Medical Corporation. The 510(k) number is K213332.

When was Multifrax Laser System approved by the FDA?

Multifrax Laser System received FDA 510(k) clearance on 2022-06-03, under approval number K213332.

What company makes Multifrax Laser System?

Multifrax Laser System is manufactured by Paradigm Medical Corporation.

What is the FDA product code for Multifrax Laser System?

The FDA product code for Multifrax Laser System is ONG.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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