The following data is part of a premarket notification filed by Shenzhen Leaflife Technology Co., Ltd with the FDA for Leaf Smooth.
| Device ID | K212697 |
| 510k Number | K212697 |
| Device Name: | Leaf Smooth |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Leaflife Technology Co., Ltd 4 F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, CN 518116 |
| Contact | Cheng Qiang |
| Correspondent | Cheng Qiang Shenzhen Leaflife Technology Co., Ltd 4 F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, CN 518116 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-25 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974223650028 | K212697 | 000 |