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FDA 510(k)

W.O.M. LASER U100

K-Number: K023041 · 2002-12-11

ApplicantW.O.M. World of Medicine AG
Decision Date2002-12-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

W.O.M. LASER U100 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine AG. It received FDA 510(k) clearance on 2002-12-11 under 510(k) number K023041. 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 W.O.M. LASER U100?

W.O.M. LASER U100 is a medical device that received FDA 510(k) clearance on 2002-12-11. The listed applicant is W.O.M. World of Medicine AG. The 510(k) number is K023041.

When did W.O.M. LASER U100 receive FDA 510(k) clearance?

W.O.M. LASER U100 received FDA 510(k) clearance on 2002-12-11, under 510(k) number K023041.

Who is the listed applicant for W.O.M. LASER U100?

The FDA 510(k) record lists W.O.M. World of Medicine AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for W.O.M. LASER U100?

The FDA product code for W.O.M. LASER U100 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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