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SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

by Olympus Surgical Technologies America

510(k) K242191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK242191 Date23 Aug 2024ClearedStatusActive

Recalls

7 recalls · 7 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1695-2026 FDA Class II initiated 27 Feb 2026
    • Ongoing Z-1694-2026 FDA Class II initiated 27 Feb 2026

    Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

  • 4 recalls, same reason

    • Ongoing Z-1920-2025 FDA Class II initiated 6 May 2025
    • Ongoing Z-1922-2025 FDA Class II initiated 6 May 2025
    • Ongoing Z-1923-2025 FDA Class II initiated 6 May 2025
    • Ongoing Z-1921-2025 FDA Class II initiated 6 May 2025

    Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

    • Ongoing Z-1715-2025 FDA Class II initiated 4 Apr 2025

    Preset treatment parameters are not consistently being used in accordance with the IFU.

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  • Withdrawn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, 22 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 SOLTIVE Laser System is a super‑pulsed thulium fiber laser platform designed for urological applications such as lithotripsy, benign prostatic hyperplasia treatment, and soft‑tissue surgery. It is offered as the Pro and Premium SuperPulsed Laser units together with dedicated SOLTIVE Laser Fibers and accessories.

The system is marketed by Olympus Surgical Technologies America and has received FDA 510(k) clearance (K242191) under product code GEX with a special clearance type. The submission was reviewed by the General Plastic Surgery advisory committee and is identified as a Class II device. The system is supplied as a complete laser platform with interchangeable fibers; specific sterility or single‑use status is not indicated in the available data.

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