Cleared Traditional

K051046 - PAINACEA MODEL XR8 INFRARED HEAT LAMP

K051046 is an FDA 510(k) clearance for PAINACEA MODEL XR8 INFRARED HEAT LAMP, manufactured by Atlantis Luminescent Products, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K051046 · Atlantis Luminescent Products, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
15d
Days
Class 2
Risk

K051046 is an FDA 510(k) clearance for the PAINACEA MODEL XR8 INFRARED HEAT LAMP. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Atlantis Luminescent Products, LLC (Houston, US). The FDA issued a Cleared decision on May 10, 2005 after a review of 15 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 - K051046

510(k) Number K051046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date May 10, 2005
Days to Decision 15 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
101d faster than avg
Panel avg: 116d · This submission: 15d
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

Intertek Testing Services
DANIEL W LEHTONEN

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 K051046.
PALOMAR LUXIR HANDPIECE
K050370 · Palomar Medical Technologies, Inc. · Jun 2005
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
K043306 · Skylark Device & Systems Co., Ltd. · Jun 2005
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
K043558 · Chongqing Xinfeng Medical Instruments Co., Ltd. · Jun 2005
LASER SYS*STIM 540, MODEL ME 540
K043586 · Mettler Electronics Corp. · May 2005
MEDX HOME
K050022 · Medx Electronics, Inc. · May 2005
K-LASER, MODELS 3,4,4D,6D
K050070 · Eltech S.R.L · Mar 2005

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.

K051046 · PAINACEA MODEL XR8 INFRARED HEAT LAMP
Download PDF FDA Summary Atlantis Luminescent …