The following data is part of a premarket notification filed by Cellreturn Co., Ltd. with the FDA for Led Mask Platinum Md.
| Device ID | K222377 |
| 510k Number | K222377 |
| Device Name: | Led Mask Platinum Md |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | CellReturn Co., LTD. 237, Namdongseo-ro. Namdong-gu Incheon, KR 21634 |
| Contact | Ilsoo Kim |
| Correspondent | Do-Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, KR 06210 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-05 |
| Decision Date | 2022-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809362081458 | K222377 | 000 |
| 00195353000279 | K222377 | 000 |