Cleared Traditional

K081505 - THERAGEM PROFESSIONAL T1002

K081505 is an FDA 510(k) clearance for THERAGEM PROFESSIONAL T1002, manufactured by Medica Health, Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K081505 · Medica Health, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
174d
Days
Class 2
Risk

K081505 is an FDA 510(k) clearance for the THERAGEM PROFESSIONAL T1002. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Medica Health, Ltd. (Deerfield Beach, US). The FDA issued a Cleared decision on November 19, 2008 after a review of 174 days - an extended review 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: 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.

View all Medica Health, Ltd. devices

FDA 510(k) Submission Details - K081505

510(k) Number K081505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date November 19, 2008
Days to Decision 174 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
58d slower than avg
Panel avg: 116d · This submission: 174d
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 199
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K081505.
BIOFLEX LD-R100 TREATMENT HEAD
K081355 · Meditech International, Inc. · Dec 2008
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
K083560 · Lighthouse Technical Innovations, Inc. · Dec 2008
NANOBEAM 940, MODEL 940-900-02
K073681 · Davaray, Inc. · Dec 2008
DPL THERAPY SYSTEM
K081570 · Led Technologies, LLC · Nov 2008
LUMINEX INFRARED LAMP SYSTEM
K082969 · Medical Laser Systems, Inc. · Oct 2008
ML830TP
K080786 · Microlight Corporation of America · Oct 2008