Model 545-45 for Neurological Surgical Application

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K860977 ↗

FDA Product Code

LLF

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Britt Corp., Inc. →

• What types of neurological procedures is the Model 545-45 Argon laser specifically designed for, and how does it differ from other lasers in this category?

  The Model 545-45 Argon laser is engineered for precision neurosurgical applications, enabling controlled tissue ablation, coagulation, or incision in operating rooms or surgical suites. Unlike other lasers, it is classified as a Class III medical device under FDA regulations and is explicitly cleared for neurosurgical use via its 510(k) pathway (K860977). Its design emphasizes focused energy delivery, making it suitable for delicate neurological procedures where precision is critical.

• Is the Model 545-45 a single-use device, or can it be reused after proper maintenance and sterilization?

  The Model 545-45 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. However, reuse requires adherence to strict maintenance and sterilization protocols to ensure safety, functionality, and compliance with regulatory standards for reusable Class III devices. Britt Corp. provides guidelines for proper care to maintain device integrity.

• What regulatory pathway was followed for FDA clearance of the Model 545-45, and what does the product code LLF indicate?

  The Model 545-45 received FDA clearance through a Traditional 510(k) pathway (K860977), with a decision date of October 16, 1986. The product code LLF categorizes it under the FDA’s classification system for lasers, specifically for neurosurgical applications. This clearance confirms the device is deemed *substantially equivalent* to a legally marketed predicate, aligning with Class III regulatory requirements for high-risk devices.

• How should the Model 545-45 be stored to preserve its functionality and sterility before first use?

  Since the Model 545-45 is a reusable device, it must be stored in a clean, dry environment—protected from moisture, dust, and physical damage—until maintenance and sterilization procedures are completed before clinical use. Britt Corp. likely provides specific storage instructions in accompanying documentation to ensure the device remains in optimal condition for sterilization and reuse.

• Who should operate the Model 545-45, and what training or expertise is required for its use in neurosurgical settings?

  The Model 545-45 is intended for use by trained professionals in operating rooms or surgical suites, such as neurosurgeons or surgical technicians with experience in laser-assisted procedures. While the device itself is cleared for neurosurgical applications, proper training in laser safety, handling, and surgical techniques is essential to ensure effective and safe use during procedures like tissue ablation or coagulation.