Cleared Traditional

K053568 - BILISOFT PHOTOTHERAPY SYSTEM

K053568 is the FDA 510(k) clearance for BILISOFT PHOTOTHERAPY SYSTEM by Lumitex, Inc.. It is a Class 2 General Hospital device (product code LBI) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K053568 · Lumitex, Inc. · General Hospital
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Apr 2006
Decision
116d
Days
Class 2
Risk

K053568 is an FDA 510(k) clearance for the BILISOFT PHOTOTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Lumitex, Inc. (Strongsville, US). The FDA issued a Cleared decision on April 17, 2006 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lumitex, Inc. devices

Submission Details

510(k) Number K053568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2005
Decision Date April 17, 2006
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 14
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K053568.
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018
BiliLux
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NANOBLUTM 500
K113206 · Draeger Medical Systems, Inc. · Feb 2012
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · Fisher &Paykel Healthcare , Ltd. · Sep 2000
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · Respironics, Inc. · May 1999