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FDA 510(k)

CANDELA VBEAM PULSED DYE LASER SYSTEM

K-Number: K021180 · 2002-07-02

ApplicantCandela Corp.
Decision Date2002-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA VBEAM PULSED DYE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corp.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021180. 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 PULSED DYE LASER SYSTEM?

CANDELA VBEAM PULSED DYE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Candela Corp.. The 510(k) number is K021180.

When did CANDELA VBEAM PULSED DYE LASER SYSTEM receive FDA 510(k) clearance?

CANDELA VBEAM PULSED DYE LASER SYSTEM received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021180.

Who is the listed applicant for CANDELA VBEAM PULSED DYE LASER SYSTEM?

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

What is the FDA product code for CANDELA VBEAM PULSED DYE LASER SYSTEM?

The FDA product code for CANDELA VBEAM PULSED DYE LASER SYSTEM 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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