Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Leaflife Technology Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
213 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-11-25 | 57 | 0 |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 | 140 | 0 |
| K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024-02-20 | 88 | 0 |
| K230362 | Planar LED mate | Shenzhen Leaflife Technology Co., Ltd. | 2023-09-11 | 213 | 0 |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Shenzhen Leaflife Technology Co., Ltd. | 2022-04-12 | 90 | 0 |
| K212697 | Leaf Smooth | Shenzhen Leaflife Technology Co., Ltd. | 2021-11-19 | 86 | 0 |
| K202980 | Laser Therapy Device | Shenzhen Leaflife Technology Co., Ltd. | 2020-11-19 | 50 | 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