Sl-100 Nd:yag Laser for Palliation of Gastro. Mali

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

510(k) Number

K871513 ↗

FDA Product Code

LNK

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• SL-100 Nd:YAG Laser for Urologic Surgery

  Class II

  FDA 510(k) K871516 Active Cleared 9 Jul 1987

• Sl-100 Nd:yag Laser for Gastrointestinal Bleeding

  Class II

  FDA 510(k) K871515 Active Cleared 9 Jul 1987

• Lightforce Lf 20/30 980NM Surgical Diode Laser System

  Class II

  FDA 510(k) K041419 Active Cleared 26 Aug 2004

• Sl-100 Nd:yag Laser for Rectal Patho. & Hemorrhoid

  Class II

  FDA 510(k) K871514 Active Cleared 9 Jul 1987

• Sl-100 Nd:yag Laser for Gynecology Use

  Class II

  FDA 510(k) K871512 Active Cleared 8 Jul 1988

• Sl-100 Nd:yag Laser for Pulmonary Obstructions

  Class II

  FDA 510(k) K871511 Active Cleared 21 Jul 1987

• What is the primary clinical purpose of the SL-100 Nd:YAG Laser, and how does it achieve this goal?

  The SL-100 Nd:YAG Laser is specifically designed for the palliative treatment of gastrointestinal obstructions. It works by delivering controlled laser energy to create tissue ablation or coagulation, which helps relieve symptoms caused by blockages in the gastrointestinal tract. This is particularly useful in reducing discomfort and improving patient outcomes when surgical intervention is not feasible.

• Is the SL-100 Nd:YAG Laser intended for single-use or reusable applications, and what considerations should be taken during its use?

  The SL-100 Nd:YAG Laser is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings by trained professionals. Since it is reusable, proper cleaning, sterilization, and maintenance are critical to ensure its functionality and safety. Additionally, standard laser safety protocols must be followed during storage and handling to prevent damage and ensure patient safety.

• What regulatory pathway was followed for the SL-100 Nd:YAG Laser, and what does this mean for its use in clinical practice?

  The SL-100 Nd:YAG Laser was cleared through the FDA’s 510(k) pathway under clearance number K871513, with a decision classification of *Substantially Equivalent* (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, placing it under Class II regulatory classification. Clinicians can rely on this clearance to confirm its compliance with FDA standards for use in palliative gastrointestinal obstruction treatments.

• What safety measures should be taken when storing and handling the SL-100 Nd:YAG Laser?

  Since the SL-100 Nd:YAG Laser is a medical laser, its storage and handling must strictly adhere to laser safety protocols to prevent accidental activation, damage, or misuse. This includes proper storage in a secure, designated area away from direct sunlight or extreme temperatures, regular maintenance checks, and ensuring only trained personnel operate it. These precautions are essential to maintain device integrity and patient safety.