Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lasertek OY — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832089 | MODEL 150K LASER COAGULATOR | Lasertek OY | 1984-01-30 | 221 | 0 |
| K828326 | UNKNOWN | Lasertek OY | 1983-03-04 | 38 | 0 |
| K781965 | LASER COAGULATOR, MODEL 41AK | Lasertek OY | 1979-02-08 | 76 | 0 |
| K782106 | COAGULATOR, MODEL 40 AARGON | Lasertek OY | 1979-02-08 | 57 | 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