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FDA 510(k)

Vbeam Prima Laser System

K-Number: K183452 · 2019-02-01

ApplicantCandela Corp.
Decision Date2019-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vbeam Prima Laser System is a medical device manufactured by Candela Corp.. It received FDA 510(k) clearance on 2019-02-01 under approval number K183452. 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 2019-02-01. It is manufactured by Candela Corp.. The 510(k) number is K183452.

When was Vbeam Prima Laser System approved by the FDA?

Vbeam Prima Laser System received FDA 510(k) clearance on 2019-02-01, under approval number K183452.

What company makes Vbeam Prima Laser System?

Vbeam Prima Laser System is manufactured by Candela Corp..

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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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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