Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Semlamp Intelligent Technology 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) |
|---|---|---|---|---|---|
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2026-04-21 | 63 | 0 |
| K240969 | IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2024-05-31 | 52 | 0 |
| K221246 | IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2022-07-07 | 66 | 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