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FDA 510(k)

REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR

K-Number: K103118 · 2010-11-19

ApplicantHoya Photonics, Inc.
Decision Date2010-11-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR 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 2010-11-19 under 510(k) number K103118. 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 REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR?

REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Hoya Photonics, Inc.. The 510(k) number is K103118.

When did REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR receive FDA 510(k) clearance?

REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR received FDA 510(k) clearance on 2010-11-19, under 510(k) number K103118.

Who is the listed applicant for REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR?

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 REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR?

The FDA product code for REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR 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.

K050696MEDLITE C1 Q-SWITCHED ND:YAG LASERK050274DIODENT II DENTAL LASER SYSTEMK041721LVI AESTHETIC LASERK032797DELIGHT DENTAL ER: YAG LASER SYSTEM

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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