Company ยท CN
Shanghai Apolo Medical Technology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2026 | K260256 | Q-Switched Nd: YAG Laser Systems Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Apr 9, 2026 | K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Jul 2, 2025 | K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) Shanghai Apolo Medical Technology Co., Ltd., CN | ONG |
| Apr 10, 2024 | K232409 | Electromagnetic Stimulation Systems Shanghai Apolo Medical Technology Co., Ltd., CN | NGX |
| Oct 13, 2022 | K221770 | Fiber Laser Treatment System Shanghai Apolo Medical Technology Co., Ltd., CN | ONG |
| Jan 28, 2022 | K203395 | Platform treatment system Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Sep 10, 2020 | K201731 | Diode Laser Body Sculpture System Shanghai Apolo Medical Technology Co., Ltd., CN | PKT |
| Jul 15, 2020 | K201109 | CO2 Laser Therapy System Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| May 28, 2020 | K200116 | PicoSecond Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| May 15, 2020 | K200746 | IPL Treatment Systems Shanghai Apolo Medical Technology Co., Ltd., CN | ONF |
| Apr 17, 2020 | K200118 | Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Aug 16, 2019 | K191349 | 980nm Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Jun 26, 2019 | K190938 | Phototherapy System Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
| Jun 17, 2019 | K190936 | Q-Switched Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd., CN | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||