Cleared Traditional

K063745 - MEDILASER, MODEL 1000

K063745 is an FDA 510(k) clearance for MEDILASER, manufactured by Laser Thera, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K063745 · Laser Thera, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
125d
Days
Class 2
Risk

K063745 is an FDA 510(k) clearance for the MEDILASER, MODEL 1000. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Laser Thera, LLC (Oklahoma City, US). The FDA issued a Cleared decision on April 23, 2007 after a review of 125 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 - K063745

510(k) Number K063745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date April 23, 2007
Days to Decision 125 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 116d · This submission: 125d
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 K063745.
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K070024 · Thor International · May 2007
HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
K063568 · Suzhou Medical Appliance Factory · Mar 2007
LC THERAPY, MODEL LCT-1000
K070400 · Litecure, LLC · Feb 2007
MODEL 2200
K062635 · Clarimedex, Inc. · Dec 2006
K063745 · MEDILASER, MODEL 1000
Download PDF FDA Summary Laser Thera, LLC