Cleared Traditional

K032229 - QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

K032229 is an FDA 510(k) clearance for QUANTUM WARP 10 LIGHT DELIVERY SYSTEM, manufactured by Quantum Devices, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K032229 · Quantum Devices, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
53d
Days
Class 2
Risk

K032229 is an FDA 510(k) clearance for the QUANTUM WARP 10 LIGHT DELIVERY SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Quantum Devices, Inc. (Grayslake, US). The FDA issued a Cleared decision on September 12, 2003 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K032229

510(k) Number K032229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date September 12, 2003
Days to Decision 53 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 116d · This submission: 53d
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

Entela, Inc.

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 220
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K032229.
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PALOMAR LIGHTCUBE
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BIOFLEX PROFESSIONAL THERAPY SYSTEM
K023621 · Meditech International, Inc. · Apr 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 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.

K032229 · QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
Download PDF FDA Summary Quantum Devices, Inc.