510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053568Substantially Equivalent

Bilisoft Phototherapy System

Lumitex Medical Devices, Inc., Strongsville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053568 is the FDA 510(k) clearance record for BILISOFT PHOTOTHERAPY SYSTEM, a class II device, cleared for Lumitex, Inc. on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 3 510(k) clearances for Lumitex Medical Devices, Inc., from to . As of , FDA records show no recalls naming K053568.

Clearance record

Decision date
Received
(116 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Lumitex, Inc. 8443 Dow Cir., Strongsville OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBI

Trailing 12 months
1 clearance under product code LBI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260