FDA Registration
Active
🇺🇸 United States
Theradome Laser Helmet
Reg #: 3013472744
·
FEI: 3013472744
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Modulus Inc.
- Registration Number
- 3013472744
- FEI Number
- 3013472744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 518 Sycamore Drive
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122950
Owner / Operator
- Firm Name
- Modulus Inc.
- Operator Number
- 10049118
- Address
- 518 Sycamore Drive
- City
- Milpitas
- State
- CA
- Postal Code
- 95035
- Country
- US
- Correspondent
- Al Young
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2015-04-15 |
Proprietary Names
Theradome Laser Helmet
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)