Device Classification Name |
light based over the counter wrinkle reduction
|
510(k) Number |
K201107 |
Device Name |
Opera Lebody (Gold), Opera Lebody (Zafiro) |
Applicant |
GTG Wellness Co., Ltd. |
767, Sinsu-ro, Suju-gu |
Yongin-si,
KR
16827
|
|
Applicant Contact |
Sang Won Jun |
Correspondent |
MDR Solutions Co., Ltd. |
1435 Kanchanapisek Rd., Bang Khae Nuea |
Bangkok,
TH
10160
|
|
Correspondent Contact |
Paweena U-Thainual |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/24/2020 |
Decision Date | 06/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|