FDA Registration
Active
🇰🇷 South Korea
OPERA LEBODY
Reg #: 3012113199
·
FEI: 3012113199
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BTB Korea Co.,Ltd
- Registration Number
- 3012113199
- FEI Number
- 3012113199
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7, Dongwon-ro, Bundang-gu,
- City
- Seongnam Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K201107
Owner / Operator
- Firm Name
- BTB Korea Co.,Ltd
- Operator Number
- 10055234
- Address
- 7, Dongwon-ro, Bundang-gu,
- City
- Seongnam
- State
- Gyeonggi
- Postal Code
- 13547
- Country
- KR
US Agent
- Business Name
- JS INTERNATIONAL HOLDING
- Contact Name
- Grace Kim
- Address
- 1442 IRVINE BLVD STE 130
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 310 5983012
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-04-04 |
Proprietary Names
OPERA LEBODY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)