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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 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.

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. 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.

Related Devices (Code: ONG)

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.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria Skin Treatment SystemAVAVA, Inc.

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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