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FDA 510(k)

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

K-Number: K033172 · 2003-10-30

ApplicantCandela Corp.
Decision Date2003-10-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corp.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K033172. 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 GENTLEYAG FAMILY OF LASER SYSTEMS?

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Candela Corp.. The 510(k) number is K033172.

When did CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS receive FDA 510(k) clearance?

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS received FDA 510(k) clearance on 2003-10-30, under 510(k) number K033172.

Who is the listed applicant for CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS?

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 GENTLEYAG FAMILY OF LASER SYSTEMS?

The FDA product code for CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS 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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