Skip to content

Olympic Mini Bili-Lite, Model 77

by Olympic Medical Corp.

510(k) K902749

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902749 Date2 Aug 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LBI
Device Class
Class II
Regulation
21 CFR Part 880.5700
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Unit, Neonatal Phototherapy, as defined by its device type and nomenclature. It is designed for the treatment of neonatal jaundice through phototherapy.

It is supplied as a reusable device intended for use in a general hospital setting. The device has received FDA 510(k) clearance under K902749 and is classified as a Class II medical device.

Other devices from Olympic Medical Corp.

See all devices from Olympic Medical Corp. →