The following data is part of a premarket notification filed by Shenzhen Leaflife Technology Co., Ltd with the FDA for Laser Therapy Device.
| Device ID | K202980 |
| 510k Number | K202980 |
| Device Name: | Laser Therapy Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shenzhen Leaflife Technology Co., Ltd Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, CN 518116 |
| Contact | Cheng Qiang |
| Correspondent | Albert Ou Shenzhen Leaflife Technology Co., Ltd Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, CN 518116 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2020-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974223650011 | K202980 | 000 |