# Soltive Tfl-Cslu

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/soltive-tfl-cslu>
- Manufacturer: [Gyrus Acmi, Inc.](https://devicerts.com/manufacturers/gyrus-acmi-inc) (United States)
- Name in the registry: SOLTIVE TFL-CSLU
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: GEX
- EMDN: Z120615 THERAPEUTIC LASERS
- GMDN: General/multiple surgical solid-state laser system (36170)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00821925044593 · UDI-DI 00821925044593 · registered 2026-09-04 · status: Active
- **GUDID** · FDA 510(k) · United States · K242191 · decision 2024-08-23 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 00821925044593 · listed 2020-03-23 · status: Listed (GUDID: in commercial distribution)

## Recalls

- Z-1695-2026 · Class II · ongoing · initiated 2026-02-27: 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.
- Z-1694-2026 · Class II · ongoing · initiated 2026-02-27: 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.
- Z-1920-2025 · Class II · ongoing · initiated 2025-05-06: 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.
- Z-1922-2025 · Class II · ongoing · initiated 2025-05-06: 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.
- Z-1923-2025 · Class II · ongoing · initiated 2025-05-06: 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.
- Z-1921-2025 · Class II · ongoing · initiated 2025-05-06: 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.
- Z-1715-2025 · Class II · ongoing · initiated 2025-04-04: Preset treatment parameters are not consistently being used in accordance with the IFU.

## Identity

- Trade name: SOLTIVE [FDA GUDID (AccessGUDID)]
- Generic name: General/multiple surgical solid-state laser system [FDA GUDID (AccessGUDID)]
- Device name: TFL-CSLU [EUDAMED]
- Model / reference: TFL-CSLU [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00821925044593 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00821925044593 [EUDAMED]
- 510(k) Number: K242191 [FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA GUDID (AccessGUDID)]
- EMDN code: Z120615 [EUDAMED]
- GMDN term: General/multiple surgical solid-state laser system (36170) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4810 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Soltive Tfl-Cslu, Gyrus Acmi, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/soltive-tfl-cslu (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/soltive-tfl-cslu.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/soltive-tfl-cslu
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.