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Soltive Tfl-Afsw

by Gyrus Acmi, Inc.

Ref TFL-AFSW

Soltive Tfl-Afsw is a device classified as Class I in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 0821925000265M), cleared under FDA 510(k) K242191 on 23 Aug 2024 and listed in FDA GUDID since 23 Mar 2020 (UDI-DI 00821925044258), active as of 25 Oct 2026. 7 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

7 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242191

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0821925000265M Basic UDI-DI 00821925044258UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242191 Date23 Aug 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00821925044258 UDI-DI Date23 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0821925000265M registered 21 Aug 2026 Active
  • FDA 510(k) K242191 decided 23 Aug 2024 Active
  • FDA GUDID UDI-DI 00821925044258 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

10 dated events

  1. Listed FDA GUDID 00821925044258
  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
  10. Registered EUDAMED 0821925000265M

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Soltive
Generic name
General/multiple surgical solid-state laser system
Device name
Soltive Surgical laser system accessories - footswitches
Model / reference
TFL-AFSW
Primary DI / UDI-DI
00821925044258
Basic UDI-DI
0821925000265M
Direct marketing DI
00821925044258
510(k) Number
FDA product code
GEX
EMDN code
Z120615 Therapeutic lasers
GMDN term
General/multiple surgical solid-state laser system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 THERAPEUTIC LASERS.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)