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
FDA 510(k) Regulatory Record - iSMART Developments, Ltd. General & Plastic Surgery ✕
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