Medical Device Manufacturer · GB , Birmingham

iSMART Developments, Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - iSMART Developments, Ltd. General & Plastic Surgery ✕
3 devices
1-3 of 3
Cleared Apr 18, 2025
handLITE (TN19S)
K250224 · ONE
General & Plastic Surgery · 81d
Cleared CT Nov 08, 2024
décoLITE LED Device
K242382 · OHS
General & Plastic Surgery · 88d
Cleared Jul 27, 2023
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
K231555 · OHS
General & Plastic Surgery · 58d
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All3 General & Plastic Surgery 3