510(k) Report

FDA applicant

Thermage, Inc.

Hayward, CA18 decisions2000–20102 recalls

FDA records 18 decisions for Thermage, Inc. (Hayward, CA) from 2000 to 2010: 18 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 48 predicates, 37 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Thermage, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2010: 12014: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Thermage, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thermage, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories17decisions
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

Whose devices does it build on?

Its devices cite 48 predicates; 37 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 85 times; 37 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013639Thermage Thermacool TC SystemThermage, Inc. · 200211cite it
  • K000944Thermage Thermacool SystemThermage, Inc. · 200010cite it
  • K033942Thermage Thermacool SystemThermage, Inc. · 20048cite it
  • K021402Thermage Thermacool TC SystemThermage, Inc. · 20027cite it
  • K003183Thermage Thermacool II SystemThermage, Inc. · 20006cite it
  • K053365Modification to Thermage Thermacool SystemThermage, Inc. · 20056cite it

What has FDA decided for it lately?

  • K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 20102 recalls
  • K072849Modification to Thermage Thermacool SystemThermage, Inc. · 2008
  • K052936Thermage Thermacool SystemThermage, Inc. · 2007
  • K061001ThermassageThermage, Inc. · 2006
  • K053365Modification to Thermage Thermacool SystemThermage, Inc. · 2005
  • K052778Thermage Thermacool Skin MarketingThermage, Inc. · 2005
  • K051710Thermage Thermacool Coupling FluidThermage, Inc. · 2005
  • K043402Thermage Thermacool SystemThermage, Inc. · 2005

All 18 as Thermage, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K101490FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for…Mar 20, 2014Class II
  • K091420Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and…Dec 15, 2010