The following data is part of a premarket notification filed by Y&j Bio Co., Ltd. with the FDA for Easy Claire.
| Device ID | K223278 |
| 510k Number | K223278 |
| 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 | Youngsam Chun |
| Correspondent | Paweena U-Thainual MDR Solutions Co., Ltd. 1435 Kanjanapisek Rd., Bang Khae Nuea Bang Khae, TH 10160 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-24 |
| Decision Date | 2022-11-17 |