Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eltech S.R.L — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120604 | K-LASER | Eltech S.R.L | 2012-05-25 | 87 | 0 |
| K091497 | K-LASER K-1200, MODEL 12 W | Eltech S.R.L | 2009-08-19 | 91 | 0 |
| K050070 | K-LASER, MODELS 3,4,4D,6D | Eltech S.R.L | 2005-03-25 | 72 | 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