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Laser Lancet LB100

by Transmedica Intl., Inc.

510(k) K980538

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980538 Date9 Jul 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Laser Lancet LB100 is a powered laser surgical instrument classified under product code GEX for general and plastic surgery. It is designed for the perforation of skin to draw capillary blood for screening purposes.

The device is supplied as a reusable instrument and was cleared through the FDA 510(k) pathway under K980538 on July 9, 1998, following a traditional review. It is manufactured by Transmedica Intl., Inc. and is intended for use in clinical settings where capillary blood sampling is required.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Laser Lancet LB100 used for?

    The Laser Lancet LB100 is designed for the perforation of skin to draw capillary blood for screening purposes, intended for use in clinical settings where capillary blood sampling is required, such as in general and plastic surgery procedures.

  • Is the Laser Lancet LB100 reusable or single-use?

    The Laser Lancet LB100 is supplied as a reusable instrument, meaning it can be cleaned, sterilized, and used multiple times in accordance with the manufacturer's reprocessing instructions, rather than being discarded after a single use.

  • How was the Laser Lancet LB100 cleared for market?

    The Laser Lancet LB100 was cleared through the FDA 510(k) pathway under submission K980538 on July 9, 1998, following a traditional review process, and was found to be substantially equivalent to a predicate device.