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FDA 510(k)

REVLITE Q-SWITCHED ND:YAG LASER

K-Number: K063112 · 2006-12-01

ApplicantHoya Conbio, Inc.
Decision Date2006-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVLITE Q-SWITCHED ND:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Conbio, Inc.. It received FDA 510(k) clearance on 2006-12-01 under 510(k) number K063112. 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?

REVLITE Q-SWITCHED ND:YAG LASER is a medical device that received FDA 510(k) clearance on 2006-12-01. The listed applicant is Hoya Conbio, Inc.. The 510(k) number is K063112.

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

REVLITE Q-SWITCHED ND:YAG LASER received FDA 510(k) clearance on 2006-12-01, under 510(k) number K063112.

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

The FDA 510(k) record lists Hoya Conbio, 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?

The FDA product code for REVLITE Q-SWITCHED ND:YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Hoya Conbio, 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.

K083899REVLITE Q-SWITCHED ND:YAG LASER SYSTEMK073158SCULPTURE 2.94 ER:YAG SYSTEMK073332V-RASER DIODE LASER SYSTEMK063384DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980K063834REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEMK060977MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523

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Related Devices (Code: GEX)

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

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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