Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuhan Dimed Laser Technology Co., 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) |
|---|---|---|---|---|---|
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Las | Wuhan Dimed Laser Technology Co., Ltd. | 2025-09-25 | 86 | 0 |
| K211977 | Medical Diode Laser Systems | Wuhan Dimed Laser Technology Co., Ltd. | 2021-10-26 | 123 | 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