Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solta Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
193 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242142 | Fraxel® FTX Laser System | Solta Medical | 2024-08-21 | 30 | 0 |
| K190555 | PowerX Lipo System | Solta Medical | 2019-05-01 | 57 | 0 |
| K190551 | VASERlipo System | Solta Medical | 2019-05-01 | 57 | 0 |
| K173759 | Thermage CPT System and Accessories | Solta Medical | 2018-01-08 | 28 | 1 |
| K170758 | Thermage FLX System and Accessories | Solta Medical | 2017-09-22 | 193 | 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