IPG Medical Thulium Fiber Lasers, Surgical Fibers, and Accessories
510(k) K232568
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232568 | Date21 Mar 2024 | StatusActive |
Recalls
-
- Ongoing Z-2554-2026
Software anomaly that causes a false display of error code 5018.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- 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, 19 Sep 2026
The IPG Medical Thulium Fiber Lasers, Surgical Fibers, and Accessories are Powered Laser Surgical Instruments (FDA classification GEX) designed for precise soft tissue manipulation. They deliver laser energy for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without endoscopic assistance. Applications include urological, lithotripsy, gastroenterological, and gynecological procedures, leveraging thulium fiber technology for controlled tissue interaction.
These devices are supplied as reusable systems, requiring proper sterilization and maintenance per manufacturer guidelines. They are intended for use in clinical settings with appropriate laser safety protocols, including MRI compatibility considerations as specified in the device documentation. The family includes various fiber types and accessories, each sized and configured for targeted surgical applications. FDA clearance (510(k) K232568) confirms compliance with regulatory standards for powered laser surgical instruments under the General, Plastic Surgery advisory committee review.
Other devices from IPG Medical Corporation
Questions
AI-generated answers, 19 Sep 2026
Are these Thulium Fiber Lasers reusable, and if so, what sterilization methods are recommended?
Yes, the IPG Medical Thulium Fiber Lasers are designed as reusable systems. The manufacturer provides specific guidelines for sterilization and maintenance to ensure proper functionality and safety. It’s important to follow these protocols closely, as improper handling could compromise device performance or patient safety.
What types of surgical procedures are these devices commonly used for?
The IPG Medical Thulium Fiber Lasers are primarily used for precise soft tissue manipulation in urological, lithotripsy, gastroenterological, and gynecological procedures. They enable functions like incision, excision, ablation, coagulation, hemostasis, and vaporization, often with or without endoscopic assistance, thanks to their thulium fiber technology.
How do I determine which fiber or accessory is best suited for my specific surgical application?
The IPG Medical family includes various fiber types and accessories, each designed for targeted surgical applications. The manufacturer’s documentation likely provides compatibility charts or guidance based on procedure type, tissue density, or anatomical location. Consulting the user manual or contacting IPG Medical’s support team can help match the right fiber or accessory to your needs.
Do these devices have any special considerations for MRI compatibility?
Yes, the IPG Medical Thulium Fiber Lasers require adherence to MRI safety protocols as outlined in the device documentation. Since laser systems can interact with magnetic fields, it’s critical to follow manufacturer instructions to ensure safe use in or around MRI environments, particularly if the procedure involves imaging or nearby equipment.