Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Bausch HealthLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Thermage with 18 510(k) clearances. The most recent is a 510(k) clearance dated Sep 8, 2010: FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US.
| Sep 8, 2010 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-USK101490 · ONG | 510(k) clearances |
| Jan 18, 2008 | MODIFICATION TO THERMAGE THERMACOOL SYSTEMK072849 · GEI | 510(k) clearances |
| Jun 12, 2007 | THERMAGE THERMACOOL SYSTEMK052936 · GEI | 510(k) clearances |
| Oct 12, 2006 | THERMASSAGEK061001 · GEI | 510(k) clearances |
| Dec 13, 2005 | MODIFICATION TO THERMAGE THERMACOOL SYSTEMK053365 · GEI | 510(k) clearances |
| Oct 20, 2005 | THERMAGE THERMACOOL SKIN MARKETINGK052778 · GEI | 510(k) clearances |
| Jul 19, 2005 | THERMAGE THERMACOOL COUPLING FLUIDK051710 · GEI | 510(k) clearances |
| Jan 14, 2005 | THERMAGE THERMACOOL SYSTEMK043402 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
