Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing Superlaser Technology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251457 | Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. | 2025-09-03 | 114 | 0 |
| K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | 2020-06-09 | 153 | 0 |
| K193464 | ND:YAG Laser | Beijing Superlaser Technology Co., Ltd. | 2020-04-13 | 119 | 0 |
| K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | 2019-12-10 | 88 | 0 |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 | 75 | 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