Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Candela Corporation · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
237 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240070 | Profound Matrix | Candela Corporation | 2024-07-01 | 174 | 0 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbea | Candela Corporation | 2023-06-01 | 56 | 0 |
| K220853 | PicoWay Laser System | Candela Corporation | 2022-10-13 | 204 | 0 |
| K212492 | Frax 1940 for Nordlys and Frax Pro | Candela Corporation | 2021-12-20 | 133 | 0 |
| K211217 | Profound Matrix | Candela Corporation | 2021-12-16 | 237 | 0 |
| K201111 | GentleMax Pro Plus | Candela Corporation | 2020-05-26 | 29 | 0 |
| K191685 | PicoWay Laser System | Candela Corporation | 2019-09-16 | 84 | 0 |
| K150326 | PicoWay Laser System | Candela Corporation | 2015-04-16 | 66 | 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