Cleared Traditional

K031329 - DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)

K031329 is an FDA 510(k) clearance for DYNATRON SOLARIS SERIES, manufactured by Dynatronics Corp.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K031329 · Dynatronics Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
177d
Days
Class 2
Risk

K031329 is an FDA 510(k) clearance for the DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIO.... Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 177 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 - K031329

510(k) Number K031329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2003
Decision Date October 22, 2003
Days to Decision 177 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
61d slower than avg
Panel avg: 116d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 78
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K031329.
HES ULTRASONIC THERAPY APPLIANCE
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SUN-RAIN ULTRASONIC THERAPY, SU-100
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US-100 PORTABLE ULTRASOUND THERAPY UNIT
K032793 · Ito Co., Ltd. · Oct 2003
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K024307 · Sybaritic, Inc. · Jul 2003
ACCOUSONIC, MODEL AS-270
K030878 · Metron Medical Australia, Pty, Ltd. · Mar 2003
K031329 · DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
Download PDF FDA Summary Dynatronics Corp.