iSMART Developments, Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
5 Wavelength LED Facemask (TN2508)510(k)Jul 24, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 24, 2026
handLITE (TN19S)510(k)Apr 18, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 18, 2025
décoLITE LED Device510(k)Nov 8, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))510(k)Jul 27, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 27, 2023