Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Mlay Intelligent Technology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | 2026-02-23 | 94 | 0 |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2025-08-14 | 120 | 0 |
| K241106 | Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2024-05-22 | 30 | 0 |
| K240264 | Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10 | Shenzhen Mlay Intelligent Technology Co., , Ltd. | 2024-03-08 | 37 | 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