Data / Medical devices / United Kingdom / I-SMART Development LTD.
I-SMART Development LTD.: FDA-registered device maker in Sutton Coldfield Birmingham, United Kingdom, 8 510(k) clearances
I-SMART Development LTD. is registered with the FDA (registration 3013481783) in Sutton Coldfield Birmingham, United Kingdom. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013481783
- Address
- 129, Green lanes Wylde Green, Sutton Coldfield Birmingham, United Kingdom, B73 5LT
- Owner or operator
- I-smart marketing/development LTD. (10061409)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 15, 2019
- Registered through
- 2026
- Brand names listed
- 5 wavelength LED facemask (TN2508), C-WAVE LED MASK FOR NECK & DECOLLETE, C-Wave Light Facial, Deesse Pro Express, Derma Expert LED Light Treatment, Dermapenworld LED Hand, Dermapenworld Neck and Decollete, Dp DERMACEUTICALS LED FACE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Specification developer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument | ONE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K260598 | 5 Wavelength LED Facemask (TN2508) | OHS | Substantially Equivalent | iSMART Developments, Ltd. | accessdata.fda.gov |
| April 18, 2025 | K250224 | handLITE (TN19S) | ONE | Substantially Equivalent | iSMART Developments, Ltd. | accessdata.fda.gov |
| November 8, 2024 | K242382 | décoLITE LED Device | OHS | Substantially Equivalent | iSMART Developments, Ltd. | accessdata.fda.gov |
| July 27, 2023 | K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | OHS | Substantially Equivalent | iSMART Developments, Ltd. | accessdata.fda.gov |
| March 22, 2022 | K214103 | Shani Darden LED light therapy mask | OLP | Substantially Equivalent | Harpar Grace International | accessdata.fda.gov |
| November 23, 2021 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | OLP | Substantially Equivalent | Mz Skin | accessdata.fda.gov |
| June 24, 2021 | K210948 | Omnilux CLEAR | OLP | Substantially Equivalent | Globalmed Technologies | accessdata.fda.gov |
| September 12, 2019 | K191629 | faceLITE | OHS | Substantially Equivalent | Ismart Marketing Svcs, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Powered Light Based Non-Laser Surgical Instrument
- All makers of Lamp, Infrared, Therapeutic Heating
Updated July 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.