FDA Registration
Active
🇺🇸 United States
TearCare MGX Technology Kit
Reg #: 3006262888
·
FEI: 3006262888
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EVOLVE MANUFACTURING TECHNOLOGIES INC.
- Registration Number
- 3006262888
- FEI Number
- 3006262888
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 47300 Bayside Parkway
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231084
Owner / Operator
- Firm Name
- EVOLVE MANUFACTURING TECHNOLOGIES INC.
- Operator Number
- 9100955
- Address
- 47300 Bayside Parkway, --
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
- Correspondent
- NOREEN - KING
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Eyelid Thermal Pulsation System | ORZ | Class 2 | Ophthalmic | No | 2025-01-21 |
Proprietary Names
TearCare MGX Technology Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)