The following data is part of a premarket notification filed by Shenzhen Leaflife Technology Co., Ltd with the FDA for Led Therapy Device (planar Led/planar Led Mini).
| Device ID | K220103 |
| 510k Number | K220103 |
| Device Name: | LED Therapy Device (Planar LED/Planar LED Mini) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shenzhen Leaflife Technology Co., Ltd 4F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., Shenzhen, CN 518116 |
| Contact | Cheng Qiang |
| Correspondent | Cheng Qiang Shenzhen Leaflife Technology Co., Ltd 4F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., 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 | 2022-01-12 |
| Decision Date | 2022-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974223650004 | K220103 | 000 |
| 06974223650103 | K220103 | 000 |