Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Fansizhe Science and Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
213 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-12-29 | 25 | 0 |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-07-14 | 89 | 0 |
| K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023 | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2023-03-28 | 88 | 0 |
| K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015 | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2022-06-30 | 30 | 0 |
| K212881 | Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2022-04-11 | 213 | 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