Model 4900 Nd:yag Laser for Neurosurgery Applica.

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K880172 ↗

FDA Product Code

LKW

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K864563 Active Cleared 9 Apr 1987

• Argon/Krypton Laser System 8500

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  FDA 510(k) K844209 Active Cleared 6 Feb 1985

• Model Hse-5M Microwave Surgery Equipment/Microtaze

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  FDA 510(k) K864413 Active Cleared 9 Dec 1986

• Lasersonics Laser Cystoscope Model Fcy-6-35

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• 870 Surgical Sys Control Pulse Modification

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  FDA 510(k) K852252 Active Cleared 27 Jun 1985

• Model 4900 Nd:yag Laser for Gastro & Genitour Appl

  Class II

  FDA 510(k) K880171 Active Cleared 11 Apr 1988

See all devices from Cooper Lasersonics, Inc. →

• Is the Model 4900 Nd:YAG Laser reusable or single-use, and how should it be maintained for long-term use?

  The Model 4900 Nd:YAG Laser is designed as a reusable medical instrument, intended for use in sterile operating room environments. Since it is reusable, proper cleaning, sterilization, and maintenance procedures must follow the manufacturer’s guidelines to ensure performance, safety, and sterility between uses. The device is not labeled as single-use, so it requires adherence to standard reusable medical device protocols.

• What types of neurosurgical procedures is this laser specifically intended for, and how precise is its tissue interaction?

  The Model 4900 Nd:YAG Laser is designed for precise tissue ablation, coagulation, and vascular occlusion during neurosurgical procedures. It uses Nd:YAG technology to deliver controlled laser beams, enabling minimal thermal spread while cutting or sealing neural tissues. This makes it suitable for applications requiring fine precision, such as tumor resection, vascular interventions, or delicate tissue manipulation, though the exact clinical indications are not specified beyond its neurosurgical laser classification.

• How is the device regulated, and what does the FDA clearance (K880172) mean for its use in clinical settings?

  The Model 4900 Nd:YAG Laser holds an FDA 510(k) clearance (K880172), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms that the device meets FDA safety and effectiveness requirements for its intended use in neurosurgical procedures, including laser precision applications. Clinicians may rely on this clearance as evidence of regulatory review, though they should always follow the manufacturer’s instructions for proper operation and maintenance.

• Are there any special storage requirements for this laser, particularly regarding environmental conditions or handling?

  While the provided data does not specify exact storage conditions, the Model 4900 Nd:YAG Laser is intended for sterile operating room environments, implying it should be stored in a clean, controlled setting to prevent contamination. Since it is reusable, it must be maintained per manufacturer guidelines to preserve performance and sterility. If the device has moving parts or optical components, proper handling—such as avoiding exposure to moisture, dust, or extreme temperatures—will be critical to longevity and safety.