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FDA 510(k)

FUTURELASE 3000/3002 ERBIUM LASER SYSTEM

K-Number: K974641 · 1998-06-08

ApplicantBuckman Co., Inc.
Decision Date1998-06-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FUTURELASE 3000/3002 ERBIUM LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1998-06-08 under 510(k) number K974641. 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 FUTURELASE 3000/3002 ERBIUM LASER SYSTEM?

FUTURELASE 3000/3002 ERBIUM LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-08. The listed applicant is Buckman Co., Inc.. The 510(k) number is K974641.

When did FUTURELASE 3000/3002 ERBIUM LASER SYSTEM receive FDA 510(k) clearance?

FUTURELASE 3000/3002 ERBIUM LASER SYSTEM received FDA 510(k) clearance on 1998-06-08, under 510(k) number K974641.

Who is the listed applicant for FUTURELASE 3000/3002 ERBIUM LASER SYSTEM?

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

What is the FDA product code for FUTURELASE 3000/3002 ERBIUM LASER SYSTEM?

The FDA product code for FUTURELASE 3000/3002 ERBIUM LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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