Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Omni Laser Skinology 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) |
|---|---|---|---|---|---|
| K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-08-16 | 189 | 0 |
| K223778 | Diode Laser Hair Removal System (RD-SLD600) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-03-31 | 105 | 0 |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 | 388 | 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