Data / Medical devices / China / Shenzhen Soga Technology Co., Ltd.
Shenzhen Soga Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Soga Technology Co., Ltd. is registered with the FDA (registration 3018318562) in Shenzhen Guangdong, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 19, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3018318562
- Address
- Room 1001, Office Building 1, Shenzhen MITK Semiconductor Co., Ltd., No. 6Shiben Road, Sanzhuli Community Shiyan Subdistrict, Bao'an District, Shenzhen Guangdong, China, 518108
- Owner or operator
- Shenzhen Soga Technology Co. Ltd. (10080731)
- Roles
- Manufacturer
- First device listed
- March 1, 2021
- Registered through
- 2027
- Brand names listed
- AIR-FLY, Dental Diode Laser (ILaser I Pro,ILaser III Pro), Dental Diode Laser (ILaser II,ILaser II Pro), Dental Diode Laser,Oral Er:YAG laser therapy system,Fiber optic tip, Dental Implant Unit SOGA - S, Electric Oral Anesthesia Injector, Family of Love Dental Laser System(Love Laser), Family of Love Dental Laser System(Love Pen) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Manufacturer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Manufacturer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | 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 19, 2026 | K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | NVK | Substantially Equivalent | Shenzhen Soga Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2022 | K211150 | Dental diode laser, SOGA Laser, ILaser II | NVK | Substantially Equivalent | Shenzhen Soga Technology Co., Ltd. | accessdata.fda.gov |
| May 10, 2022 | K214008 | Dental diode laser | NVK | Substantially Equivalent | Shenzhen Soga Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Syringe, Irrigating (Dental)
- All makers of Laser, Dental, Soft Tissue
- All makers of Powered Laser Surgical Instrument
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Probe, Periodontic
Updated May 19, 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.