Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuhan Lotuxs Technology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
274 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231910 | DermRays Revive | Wuhan Lotuxs Technology Co., Ltd. | 2024-01-30 | 215 | 0 |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Wuhan Lotuxs Technology Co., Ltd. | 2023-11-28 | 134 | 0 |
| K230090 | Diode Laser Hair Removal | Wuhan Lotuxs Technology Co., Ltd. | 2023-04-19 | 97 | 0 |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 | 86 | 0 |
| K142845 | SILKPRO laser hair removal system | Wuhan Lotuxs Technology Co., Ltd. | 2015-07-01 | 274 | 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