Cleared Traditional

K083179 - MEDILED PHOTOTHERAPY LAMP

K083179 is the FDA 510(k) clearance for MEDILED PHOTOTHERAPY LAMP by Medix I.C.S.A.. It is a Class 2 General Hospital device (product code LBI) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K083179 · Medix I.C.S.A. · General Hospital
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Feb 2009
Decision
122d
Days
Class 2
Risk

K083179 is an FDA 510(k) clearance for the MEDILED PHOTOTHERAPY LAMP. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Medix I.C.S.A. (Houston, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 122 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 Medix I.C.S.A. devices

Submission Details

510(k) Number K083179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date February 27, 2009
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
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 K083179.
neoBLUE blanket LED Phototherapy System
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K991627 · Respironics, Inc. · May 1999