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FDA 510(k)

BUFFLIGHT CLT SURGICAL LASER SYSTEM

K-Number: K000727 · 2000-09-19

ApplicantY-Beam Technologies, Inc.
Decision Date2000-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUFFLIGHT CLT SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Y-Beam Technologies, Inc.. It received FDA 510(k) clearance on 2000-09-19 under 510(k) number K000727. 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 BUFFLIGHT CLT SURGICAL LASER SYSTEM?

BUFFLIGHT CLT SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-19. The listed applicant is Y-Beam Technologies, Inc.. The 510(k) number is K000727.

When did BUFFLIGHT CLT SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

BUFFLIGHT CLT SURGICAL LASER SYSTEM received FDA 510(k) clearance on 2000-09-19, under 510(k) number K000727.

Who is the listed applicant for BUFFLIGHT CLT SURGICAL LASER SYSTEM?

The FDA 510(k) record lists Y-Beam Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUFFLIGHT CLT SURGICAL LASER SYSTEM?

The FDA product code for BUFFLIGHT CLT SURGICAL LASER SYSTEM 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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