iSMART Developments, Ltd. is one of 428 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: 5 Wavelength LED Facemask (TN2508), handLITE (TN19S), décoLITE LED Device
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.
510(k) submissions have been managed by iSMART Consulting, LLC as regulatory consultant. 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