iSMART Developments, Ltd. is one of 195 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
iSMART Developments, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: handLITE (TN19S), décoLITE LED Device, LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
4
Total
4
Cleared
0
Denied
iSMART Developments, Ltd. has 4 FDA 510(k) cleared medical devices. Based in Birmingham, GB.
Latest FDA clearance: Jul 2026. Active since 2023. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by iSMART Developments, Ltd. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - iSMART Developments, Ltd.
4 devices
Cleared
Jul 24, 2026
5 Wavelength LED Facemask (TN2508)
General & Plastic Surgery
150d
Cleared
Apr 18, 2025
handLITE (TN19S)
General & Plastic Surgery
81d
Cleared
CT
Nov 08, 2024
décoLITE LED Device
General & Plastic Surgery
88d
Cleared
Jul 27, 2023
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
General & Plastic Surgery
58d