Cleared Traditional

CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM (K030876) - FDA 510(k) Clearance

Class I Physical Medicine device.

K030876 · Cynosure, Inc. · Physical Medicine device
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Jan 2004
Decision
308d
Days
Class 1
Risk

K030876 is an FDA 510(k) clearance for the CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on January 22, 2004 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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. Elevated predicate reliance profile. 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 Cynosure, Inc. devices

Submission Details

510(k) Number K030876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2003
Decision Date January 22, 2004
Days to Decision 308 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 115d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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