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FDA 510(k)

DELIGHT DENTAL ER: YAG LASER SYSTEM

K-Number: K032797 · 2004-04-05

ApplicantHoya Photonics, Inc.
Decision Date2004-04-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DELIGHT DENTAL ER: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Photonics, Inc.. It received FDA 510(k) clearance on 2004-04-05 under 510(k) number K032797. 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 DELIGHT DENTAL ER: YAG LASER SYSTEM?

DELIGHT DENTAL ER: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-05. The listed applicant is Hoya Photonics, Inc.. The 510(k) number is K032797.

When did DELIGHT DENTAL ER: YAG LASER SYSTEM receive FDA 510(k) clearance?

DELIGHT DENTAL ER: YAG LASER SYSTEM received FDA 510(k) clearance on 2004-04-05, under 510(k) number K032797.

Who is the listed applicant for DELIGHT DENTAL ER: YAG LASER SYSTEM?

The FDA 510(k) record lists Hoya Photonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELIGHT DENTAL ER: YAG LASER SYSTEM?

The FDA product code for DELIGHT DENTAL ER: YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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