The following data is part of a premarket notification filed by Shenzhen Soga Technology Co., Ltd. with the FDA for Dental Diode Laser, Soga Laser, Ilaser Ii.
| Device ID | K211150 |
| 510k Number | K211150 |
| Device Name: | Dental Diode Laser, SOGA Laser, ILaser II |
| Classification | Laser, Dental, Soft Tissue |
| Applicant | Shenzhen Soga Technology Co., Ltd. D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street Shenzhen, CN 518110 |
| Contact | Tse Adrian |
| Correspondent | Tse Adrian Shenzhen Soga Technology Co., Ltd. D906, Yinxing Technology Building No. 1301, Sightseeing Road, Xinlan Community, Guanlan Street Shenzhen, CN 518110 |
| Product Code | NVK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2022-07-01 |