Eagle Laser Surgical Neodymium Doped Yttrium

FDA-Cleared Indications

• Use in surgical procedures requiring laser cutting, tissue ablation, or coagulation.
• Use by trained medical professionals when precise delivery of laser energy to tissue is required.

Clinical Applications

• Laser treatment of tissue during surgical procedures.
• Coagulation of tissue to control bleeding during surgery.
• Ablation or removal of targeted tissue under direct visualization or imaging guidance.
• Use in hospital operating rooms and specialized outpatient surgical settings.

Reported off-label uses

• The available FDA record does not establish additional specific off-label applications for this device model.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The device requires operation by personnel trained in surgical laser safety and the specific system.
• Appropriate laser-rated eye protection is required for everyone in the treatment area.
• The laser system and accessories must be compatible with the intended procedure, wavelength, delivery method, and tissue target.
• The record does not provide a standardized range of device sizes; configuration depends on the system and accessories supplied.
• MRI safety is not established in the available record. Treat the system and its accessories as MR-unsafe or conditionally safe only after checking the manufacturer's labeling.