Cleared Traditional

K052307 - BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM

K052307 is an FDA 510(k) clearance for BEAMER PAINLOW INFRARED LIGHT TREATMENT..., manufactured by Beamline Corporation. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K052307 · Beamline Corporation · Physical Medicine device
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Dec 2005
Decision
114d
Days
Class 2
Risk

K052307 is an FDA 510(k) clearance for the BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Beamline Corporation (Irvine, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 114 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 - K052307

510(k) Number K052307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2005
Decision Date December 16, 2005
Days to Decision 114 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 116d · This submission: 114d
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 227
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K052307.
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CURAE'LASE CL1000 IR LASER SYSTEM
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LUMINA 1600, 3300 AND 6600 SYSTEMS
K052814 · Usa Laser Biotech, Inc. · Nov 2005
CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
K052647 · American Spine Center, Ltd. · Nov 2005
K052307 · BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM
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