Nd-YAG Laser 8000 Neurosurgery Applica

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842703 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Cooper Lasersonics, Inc. →

• What is the Nd-YAG Laser 8000 Neurosurgery Applica used for?

  The Nd-YAG Laser 8000 Neurosurgery Applica is a laser surgical system designed for use in neurosurgical procedures, as indicated by its device name and classification under product code GEX. It was determined to be substantially equivalent to a predicate device through the FDA 510(k) process, confirming its intended use in surgical applications involving laser energy for tissue interaction in neurosurgery.

• Is the Nd-YAG Laser 8000 Neurosurgery Applica sterile when supplied?

  The device is supplied as a non-sterile, reusable system. This means it does not arrive in a sterile condition and must undergo appropriate cleaning and sterilization between uses according to the manufacturer’s instructions to ensure it is safe for subsequent surgical procedures.

• Can the Nd-YAG Laser 8000 Neurosurgery Applica be reused?

  Yes, the Nd-YAG Laser 8000 Neurosurgery Applica is designed as a reusable system. It is supplied non-sterile and intended for multiple uses, provided that it is properly cleaned and sterilized between each use in accordance with the manufacturer’s validated reprocessing instructions to maintain safety and functionality.

• What regulatory pathway was used for the Nd-YAG Laser 8000 Neurosurgery Applica?

  The Nd-YAG Laser 8000 Neurosurgery Applica received FDA 510(k) clearance (K842703) on October 31, 1984, through the traditional 510(k) submission process. It was determined to be substantially equivalent to a legally marketed predicate device, which is the standard regulatory route for moderate-risk medical devices like this laser surgical system.

• Who manufactures the Nd-YAG Laser 8000 Neurosurgery Applica and where are they located?

  The Nd-YAG Laser 8000 Neurosurgery Applica is manufactured by Cooper Lasersonics, Inc., located at 3420 Central Expy., Santa Clara, CA 95051, United States. This information is derived from the device’s authorization and establishment details in the FDA 510(k) record.