Soflex Limited is one of 21655 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Soflex Limited - FDA 510(k) Cleared Devices
Recent clearances: ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S, ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
3
Total
3
Cleared
0
Denied
Soflex Limited has 3 FDA 510(k) cleared medical devices. Based in Greenwood Village, US.
Historical record: 3 cleared submissions from 2011 to 2013. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Soflex Limited Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Soflex Limited
3 devices
Cleared
Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS...
Ophthalmic
237d
Cleared
Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Ophthalmic
140d
Cleared
Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY...
Ophthalmic
181d