FDA Registration
Active
🇬🇧 United Kingdom
Omnilux CLEAR
Reg #: 3013481783
·
FEI: 3013481783
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- I-SMART Development LTD.
- Registration Number
- 3013481783
- FEI Number
- 3013481783
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 129, Green lanes, Wylde Green
- City
- Sutton Coldfield Birmingham
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K210948
Owner / Operator
- Firm Name
- I-smart marketing/development LTD.
- Operator Number
- 10061409
- Address
- 129, Green lanes, Wylde Green
- City
- Sutton Coldfield
- State
- Birmingham
- Postal Code
- B73 5LT
- Country
- GB
- Correspondent
- Susan D'Arcy
US Agent
- Business Name
- i-SMART Consulting US LLC
- Contact Name
- Steven Baker
- Address
- 3495 West Kamran Ridge Cove
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
- [email protected]
- Phone
- 267 4321045
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2021-07-03 |
Proprietary Names
Omnilux CLEAR
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility