The following data is part of a premarket notification filed by Y & J Bio Co., Ltd. with the FDA for Easy Claire.
| Device ID | K213285 |
| 510k Number | K213285 |
| Device Name: | Easy Claire |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Y & J Bio Co., Ltd. B-916, 947, Hanam-daero Hanam-si, KR 12982 |
| Contact | Chun Young Sam |
| Correspondent | Paweena U-thainual MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bang Khae, TH 10160 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-03-03 |