Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solta Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
154 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Solta Medical, Inc. | 2022-12-29 | 23 | 0 |
| K132431 | THERMAGE CPT SYSTEM | Solta Medical, Inc. | 2013-09-06 | 32 | 0 |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | Solta Medical, Inc. | 2013-06-14 | 140 | 0 |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | Solta Medical, Inc. | 2012-06-05 | 14 | 0 |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2012-04-02 | 49 | 0 |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2011-05-03 | 85 | 0 |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | Solta Medical, Inc. | 2009-10-14 | 154 | 1 |
| K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | Solta Medical, Inc. | 2009-06-26 | 115 | 0 |
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