Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danish Dermatologic Development A/S — 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) |
|---|---|---|---|---|---|
| K060516 | ELLIPSE 12PL, MODEL 9ESL7228 | Danish Dermatologic Development A/S | 2006-05-15 | 77 | 0 |
| K052688 | ELLIPSE FLEX PPT, MODEL 9ESF7255 | Danish Dermatologic Development A/S | 2005-12-12 | 75 | 0 |
| K043255 | ELLIPSE LIGHT SPT | Danish Dermatologic Development A/S | 2005-02-24 | 92 | 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