iSMART Developments, Ltd.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2026-07-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260598 | 5 Wavelength LED Facemask (TN2508) | OHS | 2026-07-24 | View |
| 510(k) | K250224 | handLITE (TN19S) | ONE | 2025-04-18 | View |
| 510(k) | K242382 | décoLITE LED Device | OHS | 2024-11-08 | View |
| 510(k) | K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | OHS | 2023-07-27 | View |
No matching devices.