The following data is part of a premarket notification filed by Ningbo Hesi Electric Co., Ltd with the FDA for Infrared Light Therapy Led Facial Light Therapy Mask-derma Plus, Photons Facial Skin Care Machine Led Beauty Mask Therapy Beauty Machine.
| Device ID | K200983 |
| 510k Number | K200983 |
| Device Name: | Infrared Light Therapy Led Facial Light Therapy Mask-Derma Plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Ningbo Hesi Electric Co., Ltd No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang, Ningbo, CN 315000 |
| Contact | Ma Lulu |
| Correspondent | Cassie Lee Guangzhou GLOOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzh Guangzhou, CN 511495 |
| Product Code | OHS |
| Subsequent Product Code | ILY |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-14 |
| Decision Date | 2021-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974746830013 | K200983 | 000 |
| 06974746830006 | K200983 | 000 |