Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shenzhen Xiazhifeng Electronic Co., Ltd. · Predicate Candidate Screening

2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FLShenzhen Xiazhifeng Electronic Co., Ltd.2026-05-20860
K230549IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-Shenzhen Xiazhifeng Electronic Co., Ltd.2023-04-25560

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