Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivylaser (Beijing) Technology Co.,Ltd — 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) |
|---|---|---|---|---|---|
| K250206 | Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd | 2025-04-24 | 90 | 0 |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Ivylaser (Beijing) Technology Co.,Ltd | 2024-06-20 | 107 | 0 |
| K230025 | IVYLASER Handhold Hair Removal Machine | Ivylaser (Beijing) Technology Co.,Ltd | 2023-07-03 | 180 | 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