Cleared Traditional

CS1000 LIGHT THERAPY DEVICE (K110558) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110558 · Genesis Health Light Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K110558.
CureLight Medical Diode Laser Systems (CureLight F2-A15
K253965 · Wuhan PHOMED Technology Company , Ltd. · Mar 2026
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
K242755 · Gigaalaser Company , Ltd. · May 2025
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997 · Cure Point Therapeutics, Inc. · Oct 2024
LED Lip Perfector, model: ZC-05
K223642 · Light Tree Ventures Europe B.V. · Mar 2023
OLIZ LTB-1000A
K221189 · Ltbio Co., Ltd. · Aug 2022
CytonPro-5000
K213524 · Cytonsys, Inc. · Aug 2022