Cleared Special

Thermage CPT System and Accessories (K173759) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173759 · Solta Medical · General & Plastic Surgery device
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Jan 2018
Decision
28d
Days
Class 2
Risk

K173759 is an FDA 510(k) clearance for the Thermage CPT System and Accessories. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Solta Medical (Bothell, US). The FDA issued a Cleared decision on January 8, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solta Medical devices

Submission Details

510(k) Number K173759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2017
Decision Date January 08, 2018
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 694
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K173759.
Voyant 5mm Fusion Device
K172624 · Applied Medical Resources Corporation · Feb 2018
Stryker 90-S Max SERFAS Energy Probe
K171391 · Stryker · Jan 2018
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
K173582 · Thermigen, L.L.C · Jan 2018
Valleylab FX8 Electrosurgical Platform
K172757 · Covidien, LLC · Nov 2017
gi-4000 Electrosurgical Generator
K172805 · United States Endoscopy Group, Inc. · Oct 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation · Oct 2017