Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.2026-05-04960
K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.2026-04-09940
K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.2025-07-02900
K232409Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd.2024-04-102440
K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.2022-10-131140
K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.2022-01-284360
K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.2020-09-10780
K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.2020-07-15790
K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.2020-05-281280
K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.2020-05-15530
K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.2020-04-17870
K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.2019-08-16880
K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.2019-06-26770
K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.2019-06-17680

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