FDA 510(k)

Multifrax Laser System

Número K: K213332 · 2022-06-03

Data da decisão2022-06-03

Código do produtoONG

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the Multifrax Laser System?

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

When did Multifrax Laser System receive FDA 510(k) clearance?

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

Who is the listed applicant for Multifrax Laser System?

The FDA 510(k) record lists Paradigm Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multifrax Laser System?

The FDA product code for Multifrax Laser System is ONG.

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