Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Chuangtong Yigou 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) |
|---|---|---|---|---|---|
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 | 85 | 0 |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, C | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-03-11 | 84 | 0 |
| K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05 | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2025-06-30 | 90 | 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