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FDA 510(k)

HANDI-LASE CO2 SURGICAL LASER INSTRUMENT

K-Number: K920597 · 1992-06-04

ApplicantSorenson Laboratories, Inc.
Decision Date1992-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANDI-LASE CO2 SURGICAL LASER INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sorenson Laboratories, Inc.. It received FDA 510(k) clearance on 1992-06-04 under 510(k) number K920597. 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 HANDI-LASE CO2 SURGICAL LASER INSTRUMENT?

HANDI-LASE CO2 SURGICAL LASER INSTRUMENT is a medical device that received FDA 510(k) clearance on 1992-06-04. The listed applicant is Sorenson Laboratories, Inc.. The 510(k) number is K920597.

When did HANDI-LASE CO2 SURGICAL LASER INSTRUMENT receive FDA 510(k) clearance?

HANDI-LASE CO2 SURGICAL LASER INSTRUMENT received FDA 510(k) clearance on 1992-06-04, under 510(k) number K920597.

Who is the listed applicant for HANDI-LASE CO2 SURGICAL LASER INSTRUMENT?

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

What is the FDA product code for HANDI-LASE CO2 SURGICAL LASER INSTRUMENT?

The FDA product code for HANDI-LASE CO2 SURGICAL LASER INSTRUMENT 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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