Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sanhe LEFIS Electronics 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) |
|---|---|---|---|---|---|
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 | 60 | 0 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. | 2025-12-19 | 262 | 0 |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe Lefis Electronics Co., Ltd. | 2025-10-20 | 87 | 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