Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Borria 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) |
|---|---|---|---|---|---|
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | 2025-04-07 | 238 | 0 |
| K232939 | IPL Hair Removal Device | Shenzhen Borria Technology Co., Ltd. | 2023-12-15 | 86 | 0 |
| K213020 | IPL hair removal machine | Shenzhen Borria Technology Co., Ltd. | 2021-12-16 | 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