# Shanghai Apolo Medical Technology Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 14 (2019–2026): 14 510(k) clearances
- Product codes: GEX (9), ONG (2), ONF (1), NGX (1), PKT (1)
- 510(k) review time since 2016: median 90 days, against 90 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 24 (4 its own); citations of its devices by later devices: 23 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lutronic Corporation: 3 (https://510kreport.com/company/lutronic)
- Wontech Co., Ltd.: 2 (https://510kreport.com/company/wontech)
- Alma Lasers, Inc.: 2 (https://510kreport.com/company/alma-lasers)
- Wuhan Gigaa Optronics Technology Co., Ltd.: 1 (https://510kreport.com/company/wuhan-gigaa-optronics-technology)
- Shanghai Apolo Medical Technologies Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technologies)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)
- Wingderm Electro-Optics, Ltd.: 1 (https://510kreport.com/company/wingderm-electro-optics)

## Firms that cite its devices most
- Smedtrum Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/smedtrum-medical-technology)
- Shanghai Bele Medical Technology Co.,Ltd: 3 (https://510kreport.com/company/shanghai-bele-medical-technology)
- Shangdong Huamei Technology Co., Ltd.: 2 (https://510kreport.com/company/shangdong-huamei-technology)
- Nanjing Bestview Laser S&T Co., Ltd.: 2 (https://510kreport.com/company/nanjing-bestview-laser-s-t)
- Hebei Newangie Technology Co., Ltd.: 1 (https://510kreport.com/company/hebei-newangie-technology)
- Xuzhou Kernel Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/xuzhou-kernel-medical-equipment)
- Inwound Aps: 1 (https://510kreport.com/company/inwound)
- Aesthetic Technology, Ltd.: 1 (https://510kreport.com/company/aesthetic-technology)

## Its most-cited devices
- K200116: PicoSecond Nd: YAG Laser System (2020), cited by 6
- K190938: Phototherapy System (2019), cited by 5
- K200746: IPL Treatment Systems (2020), cited by 3
- K201109: CO2 Laser Therapy System (2020), cited by 3
- K190936: Q-Switched Nd: YAG Laser System (2019), cited by 2
- K221770: Fiber Laser Treatment System (2022), cited by 1

## Recent decisions
- K260256: Q-Switched Nd: YAG Laser Systems (May 4, 2026)
- K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298) (Apr 9, 2026)
- K251031: Fiber Laser Treatment Systems (HS-232,HS-233) (Jul 2, 2025)
- K232409: Electromagnetic Stimulation Systems (Apr 10, 2024)
- K221770: Fiber Laser Treatment System (Oct 13, 2022)
- K203395: Platform treatment system (Jan 28, 2022)
- K201731: Diode Laser Body Sculpture System (Sep 10, 2020)
- K201109: CO2 Laser Therapy System (Jul 15, 2020)

Source page: https://510kreport.com/company/shanghai-apolo-medical-technology