Medical Device Manufacturer · AU , Adelaide, South Australia

Ellex Medical Pty, Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1997

Recent clearances: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo, Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo, Eye Prime

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ellex Medical Pty, Ltd. General & Plastic Surgery ✕

4 devices
1-4 of 4
Cleared Mar 16, 2006
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS...
K052777 · GEX
General & Plastic Surgery · 164d
Cleared Aug 09, 2002
LUMENIS SELECTA DUET
K021550 · GEX
General & Plastic Surgery · 88d
Cleared Mar 15, 2001
LASEREX INTEGRE, MODEL LP2532
K003955 · GEX
General & Plastic Surgery · 84d
Cleared Nov 17, 1999
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER...
K992824 · GEX
General & Plastic Surgery · 86d
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All13 Ophthalmic 8 General & Plastic Surgery 4 Radiology 1