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FDA 510(k)

PBI MULTILASE D COPPER VAPOR LASER

K-Number: K920004 · 1992-05-14

ApplicantWm.I.Kern & Co., Inc.
Decision Date1992-05-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PBI MULTILASE D COPPER VAPOR LASER is the device name listed in this FDA 510(k) record. The listed applicant is Wm.I.Kern & Co., Inc.. It received FDA 510(k) clearance on 1992-05-14 under 510(k) number K920004. 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 PBI MULTILASE D COPPER VAPOR LASER?

PBI MULTILASE D COPPER VAPOR LASER is a medical device that received FDA 510(k) clearance on 1992-05-14. The listed applicant is Wm.I.Kern & Co., Inc.. The 510(k) number is K920004.

When did PBI MULTILASE D COPPER VAPOR LASER receive FDA 510(k) clearance?

PBI MULTILASE D COPPER VAPOR LASER received FDA 510(k) clearance on 1992-05-14, under 510(k) number K920004.

Who is the listed applicant for PBI MULTILASE D COPPER VAPOR LASER?

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

What is the FDA product code for PBI MULTILASE D COPPER VAPOR LASER?

The FDA product code for PBI MULTILASE D COPPER VAPOR LASER 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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