Model 4000 Nd:YAG Laser for Hemorrhage Control

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K844440 ↗

FDA Product Code

LKW

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Cooper Lasersonics, Inc. →

• What types of surgical procedures is the Model 4000 Nd:YAG Laser specifically designed to assist with, and how does it achieve hemostasis?

  The Model 4000 Nd:YAG Laser is designed for neurosurgical procedures where precise hemorrhage control is critical. It uses neodymium-doped yttrium aluminium garnet (Nd:YAG) technology to deliver focused laser energy, enabling targeted tissue coagulation and vascular sealing. This approach minimizes thermal damage to surrounding tissues while effectively stopping bleeding during surgery.

• Is the Model 4000 Nd:YAG Laser a single-use device, or can it be reused in multiple procedures? If reusable, what maintenance is required?

  The Model 4000 Nd:YAG Laser is a reusable medical instrument, intended for use in controlled surgical environments like operating rooms. Since it is reusable, it must be handled and maintained according to the manufacturer’s guidelines to ensure proper functionality and sterility. This includes cleaning, sterilization, and regular inspections as outlined by Cooper Lasersonics, Inc.

• How is the Model 4000 Nd:YAG Laser supplied, and what should clinicians know about its intended use environment?

  The Model 4000 Nd:YAG Laser is supplied as a reusable instrument, meaning it is not pre-packaged for single-use but must be prepared for each procedure in a sterile manner. It is intended for single-user operation in controlled surgical environments like operating rooms, where proper handling and maintenance protocols must be followed to ensure safe and effective performance.

• What regulatory pathway was followed for FDA clearance of the Model 4000 Nd:YAG Laser, and what does this mean for its use?

  The Model 4000 Nd:YAG Laser underwent a traditional 510(k) clearance pathway and was determined to be substantially equivalent to a legally marketed predicate device. This means it has been reviewed by the FDA to ensure it meets safety and effectiveness standards for its intended use in neurosurgical hemorrhage control, though clinicians should always refer to the manufacturer’s instructions for proper operation.