Pentax LH-150F Light Source

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K771739 ↗

FDA Product Code

FCW

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Pilling Identiloops

  Not classified

  FDA 510(k) K854914 Active Cleared 24 Jan 1986

• Pilling Laparoscopic Instrumentation

  Class II

  FDA 510(k) K934427 Active Cleared 10 Jan 1994

• Arterial Graft Sizers

  Not classified

  FDA 510(k) K761141 Active Cleared 6 Jan 1977

• Frazier Suction Instrument-Dispos

  Class I

  FDA 510(k) K832636 Active Cleared 14 Oct 1983

• Fiberbronchoscope (Pentax Fb-17A)

  Class II

  FDA 510(k) K760171 Active Cleared 19 Jul 1976

• Laser Bronchoscope System

  Class II

  FDA 510(k) K861921 Active Cleared 2 Jun 1986

See all devices from Pilling Co. →

• What types of endoscopic procedures is the Pentax LH-150F Light Source intended to support, and how does it enhance visualization during these procedures?

  The Pentax LH-150F Light Source is specifically designed for use in gastroenterology and urology endoscopic procedures, providing reliable illumination to improve visualization of internal anatomical structures. Its fiberoptic technology ensures consistent, bright light delivery, which is critical for diagnostic and therapeutic interventions like colonoscopies, cystoscopies, or upper GI endoscopies, where clear visibility of tissues and potential abnormalities is essential.

• Is the Pentax LH-150F Light Source single-use or reusable, and what maintenance considerations should be taken into account?

  The Pentax LH-150F Light Source is reusable, meaning it is intended for repeated use across multiple procedures. Since it is classified as a reusable medical instrument, proper cleaning, disinfection, and maintenance per manufacturer guidelines are required to ensure safety, functionality, and longevity. The device should be handled according to standard reprocessing protocols for endoscopic accessories to prevent contamination and maintain performance.

• What regulatory pathway was followed for the FDA clearance of the Pentax LH-150F Light Source, and what does this mean for its use in clinical settings?

  The Pentax LH-150F Light Source was cleared via a Traditional 510(k) pathway with a decision of *Substantially Equivalent* to a predicate device, confirming its compliance with FDA standards for Class II medical devices. This clearance indicates that the device meets regulatory requirements for safety and effectiveness in routine endoscopic applications in gastroenterology and urology, allowing its use in clinical settings as intended. The classification under FDA regulation 876.1500 further confirms its designation as a fiberoptic light source.

• Does the Pentax LH-150F Light Source require any special handling or storage conditions to maintain its performance?

  While the provided data does not specify exact storage conditions, as a reusable medical device, the Pentax LH-150F Light Source should be stored in a clean, dry environment to prevent damage or contamination. Proper packaging and protection from physical stress (e.g., drops or compression) are recommended to preserve its fiberoptic components. Follow the manufacturer’s instructions for storage and handling to ensure optimal performance and longevity.