Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dongguan Boyuan Intelligent Technology Co.,Ltd · 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) |
|---|---|---|---|---|---|
| K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-05-06 | 98 | 0 |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA44 | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-04-29 | 85 | 0 |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-10-11 | 106 | 0 |
| K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA5 | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024-04-03 | 62 | 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