25 Watt Carbon Dioxide Medical Laser for Neurology
510(k) K864166
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864166 | Date10 Feb 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LKW
- Device Class
- Class III
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Carbon Dioxide Medical Laser classified under the nomenclature for neurosurgical lasers, designed for precise tissue ablation, coagulation, and vaporisation in neurosurgical procedures. It operates at a power output of 25 watts, delivering a continuous-wave carbon dioxide laser beam for controlled surgical interventions in neurological applications.
The laser is supplied as a reusable medical instrument, intended for use in sterile operating environments by trained surgical personnel. It is regulated under the FDA 510K clearance (K864166) and falls under Device Class III, adhering to strict manufacturing and performance standards. Storage and handling must comply with laser safety protocols to ensure proper functionality and patient safety.
Questions
AI-generated answers, 18 Sep 2026
What types of neurosurgical procedures is this 25-watt carbon dioxide laser designed to assist with?
This device is specifically designed for precise tissue ablation, coagulation, and vaporization during neurosurgical procedures. Its continuous-wave carbon dioxide laser beam allows for controlled surgical interventions in neurological applications, such as tumor resection, lesion removal, or vascular procedures where fine tissue manipulation is required.
Is this laser reusable or single-use, and what does that mean for maintenance and sterilization?
The device is classified as a reusable medical instrument, meaning it is intended for repeated use in sterile operating environments. This requires adherence to strict sterilization protocols between procedures to ensure patient safety and device functionality. Maintenance must also follow manufacturer guidelines to preserve performance and safety.
What safety protocols must be followed when storing and handling this laser?
Since this is a laser device, storage and handling must comply with laser safety protocols to prevent accidental exposure or damage. The device should be stored in a secure, controlled environment away from direct sunlight or excessive heat, and only trained personnel should operate it. Follow the manufacturer’s instructions for proper setup, use, and maintenance to ensure safe and effective performance.
What power output does this laser provide, and how does that affect its use in neurosurgery?
This laser operates at a fixed power output of 25 watts, delivering a continuous-wave carbon dioxide beam. The consistent power allows for precise and controlled tissue effects—such as ablation, coagulation, or vaporization—during neurosurgical procedures, enabling surgeons to achieve fine control in delicate neurological applications.
How do I verify the regulatory compliance of this device before purchasing or using it?
This device holds an FDA 510(k) clearance under the reference number K864166, confirming it meets U.S. regulatory standards for Class III medical devices. Always verify the clearance status through official FDA databases or consult your institution’s procurement or compliance department to ensure it aligns with your facility’s requirements before use.