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FDA 510(k)

LASER LANCET LB100

K-Number: K980538 · 1998-07-09

ApplicantTransmedica Intl., Inc.
Decision Date1998-07-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER LANCET LB100 is the device name listed in this FDA 510(k) record. The listed applicant is Transmedica Intl., Inc.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K980538. 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 LASER LANCET LB100?

LASER LANCET LB100 is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Transmedica Intl., Inc.. The 510(k) number is K980538.

When did LASER LANCET LB100 receive FDA 510(k) clearance?

LASER LANCET LB100 received FDA 510(k) clearance on 1998-07-09, under 510(k) number K980538.

Who is the listed applicant for LASER LANCET LB100?

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

What is the FDA product code for LASER LANCET LB100?

The FDA product code for LASER LANCET LB100 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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