Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Home Well Trading, Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181734 | Beurer IPL 8500 device/ IPL VelvetSkin Pro | Home Well Trading, Ltd. | 2018-09-19 | 79 | 0 |
| K181121 | Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro | Home Well Trading, Ltd. | 2018-06-28 | 59 | 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