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Light-Touch Laparoscopic Model 905200 Fiberoptic

by Lifestream Int'L, Inc. 510(k)

Active United States

510(k) K891130

Overview

The Light-Touch Laparoscopic Model 905200 Fiberoptic is a laparoscopic device designed for surgical procedures. It is a fiberoptic instrument used in laparoscopic applications.

This device is manufactured by Lifestream Int'L, Inc. and has FDA 510K clearance with product code GEX. It is supplied in various sizes as indicated by the model number 905200.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891130 Date23 May 1989ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Light-Touch Laparoscopic Model 905200 Fiberoptic used for?

    The Light-Touch Laparoscopic Model 905200 Fiberoptic is designed for use in laparoscopic surgical procedures. It is a fiberoptic instrument that provides illumination during minimally invasive surgeries, allowing surgeons to visualize the surgical area clearly.

  • What sizes are available for the Light-Touch Laparoscopic Model 905200 Fiberoptic?

    The device is supplied in various sizes as indicated by the model number 905200. The specific size options are not detailed in the provided information, but the model number suggests multiple configurations are available to accommodate different surgical needs.

  • What is the regulatory status of the Light-Touch Laparoscopic Model 905200 Fiberoptic?

    The Light-Touch Laparoscopic Model 905200 Fiberoptic has FDA 510K clearance with product code GEX. It was received by the FDA on March 3, 1989, and granted clearance on May 23, 1989, with a decision code of SESE, indicating it is substantially equivalent to predicate devices.

  • Is the Light-Touch Laparoscopic Model 905200 Fiberoptic reusable or single-use?

    The provided information does not specify whether the Light-Touch Laparoscopic Model 905200 Fiberoptic is designed for single-use or multiple uses. This detail would typically be found in the device's instructions for use, which are not included in the provided data.