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Soltive Tfl-Aic

by Gyrus Acmi, Inc.

Soltive Tfl-Aic is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K242191 on 23 Aug 2024 and listed in FDA GUDID since 23 Mar 2020 (UDI-DI 00821925044616), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K242191

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK242191 Date23 Aug 2024DecidedStatusActive
United StatesGUDID listing Number00821925044616 UDI-DI Date23 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242191 decided 23 Aug 2024 Active
  • FDA GUDID UDI-DI 00821925044616 listed 23 Mar 2020 Listed

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.

Timeline

9 dated events

  1. Listed FDA GUDID 00821925044616
  2. Cleared FDA 510(k) K242191
  3. Recall initiated FDA recalls Z-1715-2025
  4. Recall initiated FDA recalls Z-1920-2025
  5. Recall initiated FDA recalls Z-1922-2025
  6. Recall initiated FDA recalls Z-1923-2025
  7. Recall initiated FDA recalls Z-1921-2025
  8. Recall initiated FDA recalls Z-1695-2026
  9. Recall initiated FDA recalls Z-1694-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Soltive
Generic name
General/multiple surgical solid-state laser system
Model / reference
TFL-AIC
Primary DI / UDI-DI
00821925044616
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical solid-state laser system

Cleared under the same submission (K242191)

and 8 more cleared under K242191

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)