Cleared Traditional

K030876 - CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE ...

K030876 is the FDA 510(k) clearance for CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE ... by Cynosure, Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K030876 · Cynosure, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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

All 14
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K030876.
OrthoGold 100
K210451 · Tissue Regeneration Technologies, LLC · May 2021
OrthoGold 100
K182682 · Tissue Regeneration Technologies · Dec 2018
D-Actor 200 Vibration Massage System
K173692 · Storz Medical AG · Apr 2018
OMRON MASSAGER MODEL HM-45
K935459 · Omron Healthcare, Inc. · Mar 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
K935462 · Omron Healthcare, Inc. · Mar 1994
OMRON MASSAGER MODEL HM-102
K935581 · Omron Healthcare, Inc. · Mar 1994