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FDA 510(k)

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

K-Number: K230990 · 2023-06-01

ApplicantCandela Corporation
Decision Date2023-06-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is a medical device manufactured by Candela Corporation. It received FDA 510(k) clearance on 2023-06-01 under approval number K230990. 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 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Candela Corporation. The 510(k) number is K230990.

When was Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) approved by the FDA?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) received FDA 510(k) clearance on 2023-06-01, under approval number K230990.

What company makes Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is manufactured by Candela Corporation.

What is the FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

The FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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

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