Cleared Traditional

K110558 - CS1000 LIGHT THERAPY DEVICE

K110558 is an FDA 510(k) clearance for CS1000 LIGHT THERAPY DEVICE, manufactured by Genesis Health Light Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 500-day FDA review.

K110558 · Genesis Health Light Corporation · Physical Medicine device
Download Printable Device Report (PDF)
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Jul 2012
Decision
500d
Days
Class 2
Risk

K110558 is an FDA 510(k) clearance for the CS1000 LIGHT THERAPY DEVICE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Genesis Health Light Corporation (Hamilton, Ontario, CA). The FDA issued a Cleared decision on July 12, 2012 after a review of 500 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Genesis Health Light Corporation devices

FDA 510(k) Submission Details - K110558

510(k) Number K110558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2011
Decision Date July 12, 2012
Days to Decision 500 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
385d slower than avg
Panel avg: 115d · This submission: 500d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 28
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