Data / Medical devices / China / Shanghai Apolo Medical Technology Co.,ltd.
Shanghai Apolo Medical Technology Co.,ltd.: FDA-registered device maker in Shanghai, China, 14 510(k) clearances
Shanghai Apolo Medical Technology Co.,ltd. is registered with the FDA (registration 3007120647) in Shanghai, China. It lists 5 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007120647
- Address
- Building 11, Lane 1566, Nanle Road, Songjiang District, Shanghai, China, 201613
- Owner or operator
- Shanghai Apolo Medical Technology Co.,Ltd. (10026423)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 16, 2019
- Registered through
- 2026
- Brand names listed
- 980nm Diode Laser Therapy Device, CO2 Laser Therapy System, Diode Laser Body Sculpture System, Diode Laser Therapy Device, DuoVive, Electromagnetic Stimulation Systems, Fiber Laser Treatment System, Fiber Laser Treatment Systems and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2026 | K260256 | Q-Switched Nd: YAG Laser Systems | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 9, 2026 | K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 2, 2025 | K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | ONG | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 10, 2024 | K232409 | Electromagnetic Stimulation Systems | NGX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 13, 2022 | K221770 | Fiber Laser Treatment System | ONG | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 28, 2022 | K203395 | Platform treatment system | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 10, 2020 | K201731 | Diode Laser Body Sculpture System | PKT | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 15, 2020 | K201109 | CO2 Laser Therapy System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 28, 2020 | K200116 | PicoSecond Nd: YAG Laser System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 15, 2020 | K200746 | IPL Treatment Systems | ONF | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 17, 2020 | K200118 | Diode Laser Therapy Device | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 16, 2019 | K191349 | 980nm Diode Laser Therapy Device | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 26, 2019 | K190938 | Phototherapy System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 17, 2019 | K190936 | Q-Switched Nd: YAG Laser System | GEX | Substantially Equivalent | Shanghai Apolo Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.