FDA Registration
Active
🇺🇸 United States
WL MDTurbo/Turbo HP
Reg #: 2027755
·
FEI: 2027755
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOLASE MG LLC
- Registration Number
- 2027755
- FEI Number
- 2027755
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 27042 Towne Centre Drive, Suite 270
- City
- Foothill Ranch
- State
- CA
- ZIP
- 92610
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090181
Owner / Operator
- Firm Name
- MEGAGEN IMPLANT CO. LTD
- Operator Number
- 9067358
- Address
- 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 42921
- Country
- KR
- Correspondent
- Kwang Bum Park
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-01-02 |
Proprietary Names
WL MDTurbo/Turbo HP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility