Portable Endoscopy System

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

510(k) Number

K950712 ↗

FDA Product Code

GCM

FDA applicant

Laser-Optik-Systeme GmbH & Co. KG

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Los 3D Vision 100

  Class II

  FDA 510(k) K930965 Active Cleared 11 Apr 1994

• Standard Endoscope

  Class II

  FDA 510(k) K972056 Active Cleared 30 Jul 1997

• Cold Light Source Los Xl-a 100

  Class II

  FDA 510(k) K952028 Active Cleared 27 Jul 1995

• Cold Light Source Los 150

  Class I

  FDA 510(k) K951829 Active Cleared 10 Jul 1995

• Xenon Light Source Pes 1

  Class II

  FDA 510(k) K992540 Active Cleared 14 Sep 1999

• Los 3D Vision 100

  Class II

  FDA 510(k) K953419 Active Cleared 8 Feb 1996

• What is the Portable Endoscopy System designed for?

  The Portable Endoscopy System is a rigid endoscope intended for direct visualization of internal body cavities and structures, primarily in gastroenterology and urology. It supports diagnostic and therapeutic procedures such as biopsies and foreign object retrieval. The system’s high-resolution imaging ensures clear visualization of the gastrointestinal and urinary tracts, enabling precise clinical assessments.

• How is the Portable Endoscopy System supplied and prepared for use?

  This device is supplied as a reusable medical instrument, meaning it must undergo thorough sterilization and maintenance between uses to ensure patient safety and device integrity. Proper cleaning, disinfection, and sterilization protocols must be followed as per regulatory guidelines to prevent cross-contamination and maintain functionality.

• Is the Portable Endoscopy System safe for MRI environments?

  No, the Portable Endoscopy System is explicitly stated as not MRI-safe. It must only be used in controlled clinical settings such as operating rooms or endoscopy suites where MRI equipment is not present, to avoid potential risks to both the patient and the device.

• What models or reference numbers are included in this system?

  The Portable Endoscopy System includes multiple rigid endoscope models, each identified by unique FEI numbers such as 3014334038, 1412854, 3013247477, and others. These models are designed to cater to various clinical needs within gastroenterology and urology, ensuring versatility in diagnostic and therapeutic applications.

• What regulatory approval does this device hold?

  The Portable Endoscopy System is authorized for use in the U.S. under FDA 510(k) clearance with the clearance number K950712. This classification indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness in its intended use.