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Uni-Fiber Non-Repairable Fiber Delivery System

by Laser Media

510(k) K872031

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872031 Date4 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LNK
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Uni-Fiber Non-Repairable Fiber Delivery System is a laser for gastro-urology use, designed to deliver laser energy via fiber optic technology for therapeutic applications in the urinary and gastrointestinal tracts. It is a non-repairable system, meaning the fiber component is intended for single use and cannot be repaired or reused after deployment.

Supplied as a single-use device, it is intended for use in clinical settings requiring laser delivery in gastro-urology procedures. The system has received FDA 510(k) clearance under K872031 and is classified as a Class II medical device. It is not MRI safe unless explicitly stated, and no sterility, size, or storage specifications are provided in the data.

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Questions

AI-generated answers, 21 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 Uni-Fiber Non-Repairable Fiber Delivery System used for?

    It is designed to deliver laser energy via fiber optic technology for therapeutic applications in the urinary and gastrointestinal tracts during gastro-urology procedures.

  • Is the Uni-Fiber Non-Repairable Fiber Delivery System reusable?

    No, it is a non-repairable system, meaning the fiber component is intended for single use and cannot be repaired or reused after deployment.

  • How is the Uni-Fiber Non-Repairable Fiber Delivery System supplied?

    It is supplied as a single-use device for clinical settings requiring laser delivery in gastro-urology procedures.

  • What regulatory pathway was used for the Uni-Fiber Non-Repairable Fiber Delivery System?

    It received FDA 510(k) clearance under K872031 and is classified as a Class II medical device.