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FDA 510(k)

DIODENT II DENTAL LASER SYSTEM

K-Number: K050274 · 2005-04-29

ApplicantHoya Photonics, Inc.
Decision Date2005-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIODENT II DENTAL 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 2005-04-29 under 510(k) number K050274. 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 DIODENT II DENTAL LASER SYSTEM?

DIODENT II DENTAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-29. The listed applicant is Hoya Photonics, Inc.. The 510(k) number is K050274.

When did DIODENT II DENTAL LASER SYSTEM receive FDA 510(k) clearance?

DIODENT II DENTAL LASER SYSTEM received FDA 510(k) clearance on 2005-04-29, under 510(k) number K050274.

Who is the listed applicant for DIODENT II DENTAL 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 DIODENT II DENTAL LASER SYSTEM?

The FDA product code for DIODENT II DENTAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Hoya Photonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

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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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