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FDA 510(k)

Vbeam Prima Laser System

K-Number: K180593 · 2018-06-05

ApplicantSyneron-Candela
Decision Date2018-06-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vbeam Prima Laser System is a medical device manufactured by Syneron-Candela. It received FDA 510(k) clearance on 2018-06-05 under approval number K180593. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vbeam Prima Laser System?

Vbeam Prima Laser System is a medical device that received FDA 510(k) clearance on 2018-06-05. It is manufactured by Syneron-Candela. The 510(k) number is K180593.

When was Vbeam Prima Laser System approved by the FDA?

Vbeam Prima Laser System received FDA 510(k) clearance on 2018-06-05, under approval number K180593.

What company makes Vbeam Prima Laser System?

Vbeam Prima Laser System is manufactured by Syneron-Candela.

What is the FDA product code for Vbeam Prima Laser System?

The FDA product code for Vbeam Prima Laser System is GEX. This falls under the Gastroenterology category.

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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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