Fiberlase II Nd:YAG Laser for Pulmonary Use

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K872351 ↗

FDA Product Code

LLO

Device Class

Class II

Regulation

21 CFR Part 874.4500

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Nd:yag Laser Single Use Fiber Delivery System

  Class II

  FDA 510(k) K860063 Active Cleared 5 Feb 1986

• Fiberlase 100 Nd: Yag Medical Laser System

  Class II

  FDA 510(k) K855197 Active Cleared 21 Jan 1986

• Single Use Laser Fiber Delivery System for Nd: Yag

  Class II

  FDA 510(k) K863428 Active Cleared 3 Dec 1986

• ND:YAG Fiberlase 100 Medical Laser System

  Class II

  FDA 510(k) K850509 Active Cleared 8 Apr 1985

• Fiberlase 100 Medical Laser System

  Class II

  FDA 510(k) K852798 Active Cleared 29 Jul 1985

• Fiberlase II Nd:yag Laser for Gastro.&Urology Use

  Class II

  FDA 510(k) K872350 Active Cleared 10 Aug 1987

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• What is the Fiberlase II Nd:YAG Laser for Pulmonary Use used for?

  The Fiberlase II Nd:YAG Laser is specifically designed for pulmonary surgical procedures, enabling precise tissue ablation, coagulation, or vaporisation within the respiratory tract. This includes interventions in the bronchi and trachea, making it ideal for minimally invasive treatments in controlled clinical environments where such procedures are required.

• Is the Fiberlase II Nd:YAG Laser reusable or single-use?

  The Fiberlase II Nd:YAG Laser is supplied as a reusable medical device. Like other reusable lasers, it requires proper maintenance, cleaning, and sterilisation between uses to ensure safety and performance. The manufacturer provides guidelines for handling and care to maintain its functionality and regulatory compliance.

• What type of sterility does the Fiberlase II Nd:YAG Laser require?

  The device is intended for use in sterile conditions, as outlined in its design and regulatory specifications. Sterility is critical for pulmonary procedures to prevent infection and ensure patient safety. The manufacturer’s instructions detail the sterilisation protocols and handling procedures to maintain this requirement.

• How is the Fiberlase II Nd:YAG Laser delivered to the treatment site?

  The laser delivers high-energy radiation through a fiber optic cable, allowing for precise targeting of tissue within the respiratory tract. This design enables minimally invasive procedures, reducing trauma and improving access to hard-to-reach areas like the bronchi and trachea.

• What regulatory pathway does the Fiberlase II Nd:YAG Laser follow?

  The Fiberlase II Nd:YAG Laser is regulated under the FDA’s 510(k) clearance pathway, classified as a Class II device. It was cleared under the traditional clearance process with the decision code SESE (Substantially Equivalent) and is authorised for pulmonary applications under 21 CFR 874.4500. This classification ensures it meets established safety and performance standards.