The following data is part of a premarket notification filed by Realton (suzhou) Medical Technology Co., Ltd. with the FDA for Surgical Green Laser System.
| Device ID | K202828 |
| 510k Number | K202828 |
| Device Name: | Surgical Green Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Realton (Suzhou) Medical Technology Co., Ltd. 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park Suzhou, CN 215123 |
| Contact | Mingzhu Liu |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan St, Panyu District Guangzhou, CN 510006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-06-04 |