Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Thermage, Inc. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

58 daysmedian FDA review time
187 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K101490FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-USThermage, Inc.2010-09-08992
K072849MODIFICATION TO THERMAGE THERMACOOL SYSTEMThermage, Inc.2008-01-181060
K052936THERMAGE THERMACOOL SYSTEMThermage, Inc.2007-06-126010
K061001THERMASSAGEThermage, Inc.2006-10-121840
K053365MODIFICATION TO THERMAGE THERMACOOL SYSTEMThermage, Inc.2005-12-13110
K052778THERMAGE THERMACOOL SKIN MARKETINGThermage, Inc.2005-10-20170
K051710THERMAGE THERMACOOL COUPLING FLUIDThermage, Inc.2005-07-19220
K043402THERMAGE THERMACOOL SYSTEMThermage, Inc.2005-01-14350
K040135THERMAGE THERMACOOL SYSTEMThermage, Inc.2004-06-211510
K033942THERMAGE THERMACOOL SYSTEMThermage, Inc.2004-02-04470
K032088MODIFICATION TO THERMACOOL TC SYSTEMThermage, Inc.2003-08-01250
K031046THERMACOOL TC SYSTEMThermage, Inc.2003-05-22500
K030142THERMACOOL TC SYSTEMThermage, Inc.2003-02-03190
K021402THERMAGE THERMACOOL TC SYSTEMThermage, Inc.2002-11-051870
K013639THERMAGE THERMACOOL TC SYSTEMThermage, Inc.2002-01-29850
K013034MODIFICATION TO: THERMACOOL IIAThermage, Inc.2001-10-04240
K003183THERMAGE THERMACOOL II SYSTEMThermage, Inc.2000-12-08580
K000944THERMAGE THERMACOOL SYSTEMThermage, Inc.2000-07-191180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda