FDA Registration
Active
🇬🇧 United Kingdom
I-SMART Development LTD.
Reg #: 3013481783
·
FEI: 3013481783
·
Expires 2026
Products
4
Proprietary Names
42
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- I-SMART Development LTD.
- Registration Number
- 3013481783
- FEI Number
- 3013481783
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 129, Green lanes, Wylde Green
- City
- Sutton Coldfield Birmingham
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K250224
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 |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2019-12-15 |
| Powered Light Based Non-Laser Surgical Instrument | ONE | Class 2 | General, Plastic Surgery | No | 2025-08-24 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-09-15 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2023-09-15 |
Proprietary Names
Omnilux Contour Neck and Decollete
UnveiLED Neck & Decollete
handLITE
UNveiLED Glove
decoLITE RIO
Dermapenworld Neck and Decollete
Omnilux Contour Glove
decoLITE
Dermapenworld LED Hand
C-WAVE LED MASK FOR NECK & DECOLLETE
LightMAX MiniPro Eyeconic
Omnilux Mini Blemish Eraser
LUMA Blemish
Omnilux Mini Skin Corrector
SkinLED LUMA Bright
Smoothskin DuoLux Mini Collagen+
LUMA Revive
Omnilux Mini Eye Brightener
Eye Regenerate
Omnilux CLEAR
MZ Skin LightMAX Supercharged LED Mask 2
Dp DERMACEUTICALS LED+ FACE
Kandyway Eternal Glow MD Face
Deesse Pro Express
faceLITE RIO
faceLITE USA
UNveiLED
Omnilux Mens
Derma Expert LED Light Treatment
Omnilux Contour
The Dynamo Deep LED Collagen-Boosting Mask
Light therapy LED facemask from City Beauty
faceLITE
UK SKIN LED Dual Light Pro Therapy Face Mask
Glo mask
Dp DERMACEUTICALS LED FACE
PRIORI Next Generation LED Facemask
Smoothskin DuoLux
C-Wave Light Facial
LUMA PRO
Shani Darden LED light therapy mask
EOS-X by Deesse PRO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device