Fiberlase II Nd:yag Laser for Gastro.&Urology Use
by Laser Media
510(k) K872350
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872350 | Date10 Aug 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LNK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Fiberlase II Nd:Yag Laser is a Laser for Gastro-Urology Use, classified under FDA regulation 878.4810. This device employs neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology to deliver high-energy laser beams for precise tissue ablation, coagulation, or incision in gastrointestinal and urological procedures. Its design supports applications in endoscopy, lithotripsy, and other minimally invasive treatments where controlled laser energy is required.
The Fiberlase II is supplied as a reusable medical device, intended for use in sterile clinical settings by trained professionals. It operates under FDA 510(k) clearance (K872350) and falls under Class II regulatory classification, with a review panel designation for Gastroenterology/Urology. No specific MRI safety or single-use indications are noted in the regulatory data. Storage and handling must comply with manufacturer guidelines to maintain device integrity and performance.
Other devices from Laser Media
Questions
AI-generated answers, 1 Oct 2026
What is the Fiberlase II Nd:YAG Laser used for in clinical settings?
The Fiberlase II Nd:YAG Laser is designed for controlled tissue ablation, coagulation, or incision in gastrointestinal and urological procedures. This includes applications in endoscopy and lithotripsy, where high-energy laser beams are required for minimally invasive treatments. Its neodymium-doped yttrium aluminium garnet (Nd:YAG) technology ensures precision in procedures like cutting or sealing tissues without excessive heat damage.
Is the Fiberlase II Nd:YAG Laser a single-use or reusable device?
The Fiberlase II Nd:YAG Laser is a reusable medical device. It is intended for use in sterile clinical settings by trained professionals, requiring adherence to manufacturer guidelines for cleaning, maintenance, and sterilization to ensure device integrity and performance over repeated uses.
What regulatory clearance does the Fiberlase II Nd:YAG Laser hold?
The Fiberlase II Nd:YAG Laser holds FDA 510(k) clearance under the designation K872350. It is classified as a Class II device under FDA regulation 878.4810, with a review panel designation for Gastroenterology/Urology. This clearance indicates it is substantially equivalent to a legally marketed device and meets regulatory standards for safety and effectiveness.
How should the Fiberlase II Nd:YAG Laser be stored and handled?
The Fiberlase II Nd:YAG Laser must be stored and handled according to the manufacturer’s guidelines to preserve its performance and integrity. Proper storage includes protecting it from physical damage, moisture, and contamination. Regular maintenance, including cleaning and sterilization procedures, is essential to ensure the device remains functional for repeated clinical use.
Does the Fiberlase II Nd:YAG Laser have any specific MRI safety considerations?
The regulatory data for the Fiberlase II Nd:YAG Laser does not specify any particular MRI safety considerations. However, as with all laser devices, it is important to follow standard MRI safety protocols when the device is in proximity to MRI environments to avoid interference or hazards. Always consult the manufacturer’s instructions for guidance.