Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Led Technologies, LLC — 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) |
|---|---|---|---|---|---|
| K141181 | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES | Led Technologies, LLC | 2015-03-31 | 328 | 0 |
| K101382 | DPL NUVE | Led Technologies, LLC | 2010-11-09 | 176 | 0 |
| K081570 | DPL THERAPY SYSTEM | Led Technologies, LLC | 2008-11-07 | 156 | 1 |
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