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FDA 510(k)

MEDLITE C1 Q-SWITCHED ND:YAG LASER

K-Number: K050696 · 2005-06-17

ApplicantHoya Photonics, Inc.
Decision Date2005-06-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE C1 Q-SWITCHED ND:YAG LASER 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 2005-06-17 under 510(k) number K050696. 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 MEDLITE C1 Q-SWITCHED ND:YAG LASER?

MEDLITE C1 Q-SWITCHED ND:YAG LASER is a medical device that received FDA 510(k) clearance on 2005-06-17. The listed applicant is Hoya Photonics, Inc.. The 510(k) number is K050696.

When did MEDLITE C1 Q-SWITCHED ND:YAG LASER receive FDA 510(k) clearance?

MEDLITE C1 Q-SWITCHED ND:YAG LASER received FDA 510(k) clearance on 2005-06-17, under 510(k) number K050696.

Who is the listed applicant for MEDLITE C1 Q-SWITCHED ND:YAG LASER?

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 MEDLITE C1 Q-SWITCHED ND:YAG LASER?

The FDA product code for MEDLITE C1 Q-SWITCHED ND:YAG LASER 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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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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