The following data is part of a premarket notification filed by Duplex International Trading Limited with the FDA for Project E Beauty Led Light Therapy Mask (model: Pe730).
| Device ID | K214101 |
| 510k Number | K214101 |
| Device Name: | Project E Beauty LED Light Therapy Mask (Model: PE730) |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Duplex International Trading Limited B1, 10/F, Block 2, Golden Dragon Ind Centre, 162-170 Tai Lin Pai Road, Kwai Chung, NT Hong Kong, CN |
| Contact | Patrick Lee |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-29 |
| Decision Date | 2022-03-23 |