Cleared Traditional

K033555 - KENKOWAVE INFRARED PAIN TREATMENT SYSTEM

K033555 is an FDA 510(k) clearance for KENKOWAVE INFRARED PAIN TREATMENT SYSTEM, manufactured by Kaylight Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K033555 · Kaylight Corporation · Physical Medicine device
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Mar 2004
Decision
111d
Days
Class 2
Risk

K033555 is an FDA 510(k) clearance for the KENKOWAVE INFRARED PAIN TREATMENT SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Kaylight Corporation (Woodbury, US). The FDA issued a Cleared decision on March 2, 2004 after a review of 111 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K033555

510(k) Number K033555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date March 02, 2004
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 116d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
SUSAN GILL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K033555.
RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · Rich-Mar Corp. · May 2004
MLT-1000 IR LASER SYSTEM
K033986 · Medical Laser Therapeutics LP · Mar 2004
TH0R DDII IR LAMP SYSTEM
K033923 · Thor Intl. · Mar 2004
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
K033768 · Altus Medical, Inc. · Feb 2004
ALT LASER, MODEL VTR 75
K031612 · Avicenna Laser Technology, Inc. · Dec 2003
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · Skytech Enterprises, Inc. · Dec 2003

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K033555 · KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
Download PDF Kaylight Corporation