Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lap GmbH Laser Applikationen · 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) |
|---|---|---|---|---|---|
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026-06-04 | 258 | 0 |
| K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024-03-29 | 266 | 0 |
| K200907 | Thales 3D Mr Scanner | Lap GmbH Laser Applikationen | 2020-06-03 | 58 | 0 |
| K173926 | DORADOnova MR3T | Lap GmbH Laser Applikationen | 2018-09-14 | 262 | 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