Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Apolo Medical Technology Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
244 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 | 96 | 0 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 | 94 | 0 |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 | 90 | 0 |
| K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2024-04-10 | 244 | 0 |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 | 114 | 0 |
| K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022-01-28 | 436 | 0 |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 | 78 | 0 |
| K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-07-15 | 79 | 0 |
| K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-28 | 128 | 0 |
| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 | 53 | 0 |
| K200118 | Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2020-04-17 | 87 | 0 |
| K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019-08-16 | 88 | 0 |
| K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2019-06-26 | 77 | 0 |
| K190936 | Q-Switched Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | 2019-06-17 | 68 | 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