Thulium Fiber Laser System TFL-A; Thulium Fiber Laser System TFL-B
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Thulium Fiber Laser System EUDAMED
- Model / Reference
- TFL-A, TFL-B EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973204211425 EUDAMED
- Basic UDI-DI
- 697320421TFLPC EUDAMED
- Direct Marketing DI
- 06973204211425 EUDAMED
- 510(k) Number
- K252787 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Thulium Fiber Laser System (TFL-A and TFL-B) is a medical laser device designed for precise tissue ablation and coagulation. It operates using thulium fiber laser technology, delivering high-energy laser pulses for surgical applications in dermatology and plastic surgery, including skin resurfacing, tattoo removal, and vascular lesion treatment.
These systems are supplied as reusable medical devices, intended for use in controlled clinical settings such as outpatient clinics and surgical centers. They are not classified as sterile single-use items and require proper maintenance and cleaning per manufacturer guidelines. The devices comply with FDA 510(k) clearance under the General, Plastic Surgery advisory committee and meet MDR requirements. No MRI safety information is specified.
Frequently asked questions
What types of surgical procedures is the Thulium Fiber Laser System (TFL-A/B) primarily used for in dermatology and plastic surgery?
The Thulium Fiber Laser System (TFL-A and TFL-B) is designed for precise tissue ablation and coagulation, making it suitable for procedures like skin resurfacing, tattoo removal, and treating vascular lesions. Its thulium fiber laser technology allows controlled energy delivery for these dermatological and plastic surgery applications.
Are the Thulium Fiber Laser Systems (TFL-A/B) meant for single-use or reusable in a clinical setting?
The Thulium Fiber Laser Systems (TFL-A and TFL-B) are not single-use devices. They are classified as reusable medical devices and require proper maintenance, cleaning, and adherence to manufacturer guidelines for safe, repeated use in controlled clinical environments like outpatient clinics or surgical centers.
How is the Thulium Fiber Laser System (TFL-A/B) regulated, and what advisory committee was involved in its FDA review?
The Thulium Fiber Laser System (TFL-A/B) holds FDA 510(k) clearance under the General, Plastic Surgery advisory committee (reviewed under product code GEX). It was determined *substantially equivalent* to a predicate device, and the review was conducted by the Surgical Devices and Specialty Products (SU) advisory committee. Additionally, it complies with MDR (Medical Device Regulation) requirements.
What should clinicians consider regarding storage or handling of the Thulium Fiber Laser System (TFL-A/B) before use?
Since the Thulium Fiber Laser Systems (TFL-A/B) are reusable, they must be stored in a clean, dry environment and handled according to manufacturer guidelines to ensure proper maintenance and hygiene. Unlike single-use devices, they require regular cleaning and servicing between procedures to maintain performance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252787 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA 510(k) K252787 24 fields · synced Oct 6, 2026
- EUDAMED ec9ecfa4-637a-453b-8ef3-a5ead662be08 61 fields · synced Jul 25, 2026