ND:YAG Fiberlase 100 Medical Laser System

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

510(k) Number

K850509 ↗

FDA Product Code

LNK

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Fiberlase II Nd:YAG Laser for Pulmonary Use

  Class II

  FDA 510(k) K872351 Active Cleared 11 Dec 1987

• 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

• 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 types of surgical procedures is the ND:YAG Fiberlase 100 Medical Laser System primarily used for?

  The ND:YAG Fiberlase 100 is designed for precise tissue ablation, coagulation, and vaporization in gastro-urological procedures. This includes applications within the urological and gastrointestinal tracts, such as endoscopic surgeries where controlled laser energy is required. While its FDA clearance references general and plastic surgery, its FDA product code (LNK) and regulatory classification (878.4810) specifically align it with gastro-urology use.

• Is the ND:YAG Fiberlase 100 a single-use or reusable device, and how should it be maintained?

  The system is reusable, intended for use in sterile environments like operating rooms or endoscopic suites. Proper maintenance and storage are critical, as outlined in the device’s operational manual, to ensure reliability and compliance with FDA requirements for Class II medical lasers.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The ND:YAG Fiberlase 100 received FDA 510(k) clearance under the *Traditional* pathway (K-number K850509), with a Substantially Equivalent (SESE) determination. This means it was deemed comparable to a legally marketed predicate device, allowing its use in FDA-authorized applications—primarily for tissue ablation/coagulation in urology/gastroenterology—while adhering to Class II device regulations.

• How is the device’s sterility ensured during use, given it’s reusable?

  Since the system is reusable, sterility must be maintained through proper cleaning, disinfection, and sterilization protocols as specified in the manufacturer’s instructions. The device is intended for controlled clinical environments (e.g., ORs, endoscopic suites) where sterile conditions are standard practice, ensuring safe reuse between procedures.

• Are there specific storage requirements for the ND:YAG Fiberlase 100 to preserve its functionality?

  While the provided data doesn’t detail exact storage conditions, reusable medical lasers like this typically require protection from moisture, extreme temperatures, and physical damage to maintain performance. The manufacturer’s operational manual (referenced in the FDA clearance) would outline precise storage guidelines, including environmental controls and handling instructions.