Olympic Bili-Lite

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

510(k) Number

K940996 ↗

FDA Product Code

LBI

Device Class

Class II

Regulation

21 CFR Part 880.5700

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Olympic Smart Scale Care Center

  Class II

  FDA 510(k) K920423 Active Cleared 11 Jun 1992

• Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330

  Class II

  FDA 510(k) K020335 Active Cleared 18 Jun 2002

• Lube-Lok

  Class I

  FDA 510(k) K781695 Active Cleared 1 Nov 1978

• Olympic Bili-Lite-Pad(Tm)

  Class II

  FDA 510(k) K901987 Active Cleared 16 Jul 1990

• Olympix Mini-Pasteurmatic (58210)

  Class II

  FDA 510(k) K972193 Active Cleared 5 Sep 1997

• Warm-Scale

  Class I

  FDA 510(k) K952649 Active Cleared 15 Aug 1995

See all devices from Olympic Medical Corp. →

• What is the Olympic Bili-Lite Model 80/81 used for?

  The Olympic Bili-Lite Model 80/81 is designed specifically to treat hyperbilirubinemia in newborns by emitting precise wavelengths of light. This non-invasive phototherapy breaks down excess bilirubin in an infant’s bloodstream, helping to prevent complications associated with jaundice. It is intended for use in neonatal care settings where elevated bilirubin levels require medical intervention.

• Is the Olympic Bili-Lite Model 80/81 single-use or reusable?

  The Olympic Bili-Lite Model 80/81 is a reusable medical device. It is intended for use in general hospital environments and requires proper maintenance as outlined in its instruction manual to ensure safety and effectiveness. Reusability is common for phototherapy units to balance cost and clinical needs.

• What regulatory approval does the Olympic Bili-Lite Model 80/81 hold?

  The Olympic Bili-Lite Model 80/81 holds FDA 510(k) clearance under the reference number K940996. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 880.5700. The device is classified as a Class II medical device under the FDA’s classification system.

• How should the Olympic Bili-Lite Model 80/81 be stored?

  Storage conditions for the Olympic Bili-Lite Model 80/81 are defined by the manufacturer to ensure operational integrity and longevity. While specific details are not provided in the data, standard practices for reusable medical phototherapy units typically involve clean, dry environments protected from extreme temperatures, humidity, and direct sunlight. Always follow the manufacturer’s guidelines in the instruction manual for optimal storage.

• What maintenance is required for the Olympic Bili-Lite Model 80/81?

  As a reusable device, the Olympic Bili-Lite Model 80/81 requires regular maintenance to ensure its proper function and safety. This includes cleaning, calibration, and inspection as detailed in the manufacturer’s instruction manual. Maintenance protocols are critical for phototherapy units to prevent malfunctions that could compromise treatment efficacy or patient safety. Adherence to these guidelines is essential for compliance with regulatory standards.