Cleared Traditional

K121363 - DIOWAVE LOW LEVEL COLD LASER SYSTEM

K121363 is an FDA 510(k) clearance for DIOWAVE LOW LEVEL COLD LASER SYSTEM, manufactured by Technological Medical Advancments, Inc. (Tma). The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K121363 · Technological Medical Advancments, Inc. (Tma) · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
200d
Days
Class 2
Risk

K121363 is an FDA 510(k) clearance for the DIOWAVE LOW LEVEL COLD LASER SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Technological Medical Advancments, Inc. (Tma) (West Palm Beach, US). The FDA issued a Cleared decision on November 23, 2012 after a review of 200 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.

FDA 510(k) Submission Details - K121363

510(k) Number K121363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2012
Decision Date November 23, 2012
Days to Decision 200 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
84d slower than avg
Panel avg: 116d · This submission: 200d
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
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K121363 · DIOWAVE LOW LEVEL COLD LASER SYSTEM
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