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FDA 510(k)

SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

K-Number: K000317 · 2000-10-27

ApplicantTissue Medical Lasers, Inc.
Decision Date2000-10-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Medical Lasers, Inc.. It received FDA 510(k) clearance on 2000-10-27 under 510(k) number K000317. 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 SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM?

SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM is a medical device that received FDA 510(k) clearance on 2000-10-27. The listed applicant is Tissue Medical Lasers, Inc.. The 510(k) number is K000317.

When did SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM receive FDA 510(k) clearance?

SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM received FDA 510(k) clearance on 2000-10-27, under 510(k) number K000317.

Who is the listed applicant for SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM?

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

What is the FDA product code for SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM?

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

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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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