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FDA 510(k)

INCISOR I PULSED ND:YAG LASER SYSTEM

K-Number: K922901 · 1992-11-20

ApplicantBuckman Co., Inc.
Decision Date1992-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCISOR I PULSED ND:YAG 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 1992-11-20 under 510(k) number K922901. 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 INCISOR I PULSED ND:YAG LASER SYSTEM?

INCISOR I PULSED ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-20. The listed applicant is Buckman Co., Inc.. The 510(k) number is K922901.

When did INCISOR I PULSED ND:YAG LASER SYSTEM receive FDA 510(k) clearance?

INCISOR I PULSED ND:YAG LASER SYSTEM received FDA 510(k) clearance on 1992-11-20, under 510(k) number K922901.

Who is the listed applicant for INCISOR I PULSED ND:YAG 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 INCISOR I PULSED ND:YAG LASER SYSTEM?

The FDA product code for INCISOR I PULSED ND:YAG 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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