Endocoagulator Models 5, 8 & 20 Argon Laser - 20 Argon Laser

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

510(k) Number

K870773 ↗

FDA Product Code

LLF

Models / Variants

5

8

20 Argon Laser

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Q-11 Ophthalmic Laser

  Class II

  FDA 510(k) K931499 Active Cleared 19 Aug 1993

• Smart Plug

  Class II

  FDA 510(k) K950120 Active Cleared 11 Aug 1995

• Hgm Illuminating Imaging Endocular Probe

  Class II

  FDA 510(k) K931784 Active Cleared 1 Mar 1994

• Endocoagulator Models 8 and 20 Argon Laser

  Class II

  FDA 510(k) K873773 Active Cleared 13 Oct 1987

• Hgm Aspirating Endoocular(Tm) Probe

  Class II

  FDA 510(k) K925663 Active Cleared 17 Aug 1993

• Laser Photocoagulator

  Not classified

  FDA 510(k) K837306 Active Cleared 21 Apr 1983

See all devices from Hgm, Inc. →

• What types of surgical procedures is this Argon Laser Endocoagulator primarily used for, and why is it considered suitable for those applications?

  This Endocoagulator is designed specifically for neurosurgical procedures where precise tissue coagulation and hemostasis are critical. Its focused laser energy allows for controlled bleeding reduction in delicate brain or spinal surgeries, minimizing damage to surrounding tissues. The device’s precision is particularly valuable in neurosurgery due to the sensitivity of neural structures.

• Is this device single-use or reusable, and what maintenance considerations should be kept in mind during its use?

  This Endocoagulator is a reusable medical instrument, meaning it is intended for repeated use in controlled surgical environments. Proper handling, cleaning, and maintenance are essential to ensure its safety and efficacy over time. While no specific sterility requirements beyond standard surgical protocols are mentioned, adherence to rigorous cleaning and sterilization procedures is critical to prevent contamination and maintain performance.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use in clinical settings?

  The Endocoagulator received FDA clearance through a 510(k) premarket notification process, specifically under the product code LLF and classified as Class III. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of the device’s compliance with FDA requirements for neurosurgical coagulation tools.

• Are there different models available, and how do they differ in terms of specifications or intended use?

  Yes, this device comes in three models: 5, 8, and 20. While the exact differences in specifications (such as power output, fiber size, or energy delivery settings) are not detailed in the provided data, the models likely cater to varying clinical needs—such as different tissue depths or coagulation intensities. The manufacturer’s documentation or technical specifications would clarify how each model is optimized for specific neurosurgical applications.