The following data is part of a premarket notification filed by Yrs Group Inc with the FDA for Synergy Marble (model: Opasm).
| Device ID | K220064 |
| 510k Number | K220064 |
| Device Name: | Synergy Marble (Model: Opasm) |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | YRS Group Inc 5151 S Procyon St Suite 105 Las Vegas, NV 89118 |
| Contact | Raphael Arvili |
| 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 | 2022-01-10 |
| Decision Date | 2022-07-22 |