Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BEIJING SYNTECH LASER 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) |
|---|---|---|---|---|---|
| K123483 | DIODE LASER | BEIJING SYNTECH LASER CO., LTD. | 2013-04-21 | 159 | 0 |
| K113018 | APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NIC | BEIJING SYNTECH LASER CO., LTD. | 2012-12-14 | 430 | 0 |
| K110434 | TRIXEL CO2 LASER | BEIJING SYNTECH LASER CO., LTD. | 2011-04-19 | 63 | 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