Medical Device Manufacturer · US , Hopkinton , MA

El.En S.P.A.

14 submissions · 14 cleared · Since 2014
14
Total
14
Cleared
0
Denied

El.En S.P.A. has 14 FDA 510(k) cleared general & plastic surgery devices. Based in Hopkinton, US.

Latest FDA clearance: Aug 2025. Active since 2014.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

14 devices
1–12 of 14
Olo
K251432 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Aug 2025 90d
Deka Bluebeam
K243683 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Jun 2025 195d
DEKA LOTUS
K250281 · ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect · General & Plastic Surgery
Feb 2025 26d
MOTUS PRO Family
K241459 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Jun 2024 29d
DEKA LOTUS
K233473 · ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect · General & Plastic Surgery
May 2024 204d
DEKA TORO
K240752 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
May 2024 58d
NIRVANA
K234057 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Apr 2024 110d
SMARTXIDE PRO
K240537 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Mar 2024 23d
Smartxide Tetra Pro
K240497 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Mar 2024 21d
DEKA LILY
K233470 · NGX Stimulator, Muscle, Powered, For Muscle Conditioning · Physical Medicine
Dec 2023 55d
DEKA AGAIN PRO family
K233090 · GEX Powered Laser Surgical Instrument · General & Plastic Surgery
Oct 2023 31d
DEKA PHYSIQ 360
K231971 · PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use · General & Plastic Surgery
Sep 2023 85d
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All14 General & Plastic Surgery 12 Physical Medicine 2