Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Syneron Candela Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017-05-25 | 86 | 0 |
| K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017-02-01 | 153 | 0 |
| K161043 | Profound System | Syneron Candela Corporation | 2016-09-12 | 152 | 0 |
| K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016-07-05 | 125 | 0 |
| K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016-03-02 | 84 | 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