Medical Device Manufacturer · US , Oceanside , NY

Ellman International, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2006

Recent clearances: PELLEFIRM, PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC, SURGITRON 4.0 DUAL RF S5-IEC

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ellman International, Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Feb 20, 2014

General & Plastic Surgery · 154d

Cleared Sep 25, 2013

PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC

General & Plastic Surgery · 29d

Cleared Jul 12, 2013

SURGITRON 4.0 DUAL RF S5-IEC

General & Plastic Surgery · 254d

Cleared Feb 28, 2008

ELLMAN NOBLE ALLOY ELECTRODES

General & Plastic Surgery · 290d