Cleared Traditional

K053568 - BILISOFT PHOTOTHERAPY SYSTEM

K053568 is an FDA 510(k) clearance for BILISOFT PHOTOTHERAPY SYSTEM, manufactured by Lumitex, Inc.. The device is a Class 2 General Hospital device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K053568

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
Combination Product No
PCCP Authorized No
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.

LBI Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K053568.
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
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LULLABY
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WALLABY 4
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K011549 · Ohmeda Medical · Jul 2001
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