The following data is part of a premarket notification filed by Gtg Wellness Co., Ltd. with the FDA for Opera Lebody (gold), Opera Lebody (zafiro).
| Device ID | K201107 |
| 510k Number | K201107 |
| Device Name: | Opera Lebody (Gold), Opera Lebody (Zafiro) |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | GTG Wellness Co., Ltd. 767, Sinsu-ro, Suju-gu Yongin-si, KR 16827 |
| Contact | Sang Won Jun |
| Correspondent | Paweena U-thainual MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bangkok, 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 | 2020-04-24 |
| Decision Date | 2020-06-22 |