Cleared Traditional

DERMAWAVE 5000 COMBI MAX SYSTEM (K040121) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040121 · Dermawave, LLC · Physical Medicine device
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Mar 2004
Decision
57d
Days
Class 2
Risk

K040121 is an FDA 510(k) clearance for the DERMAWAVE 5000 COMBI MAX SYSTEM. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Dermawave, LLC (Loxahatchee, US). The FDA issued a Cleared decision on March 17, 2004 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dermawave, LLC devices

Submission Details

510(k) Number K040121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date March 17, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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.