ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K110261
Device Name ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
Applicant
SOFLEX LIMITED
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
SOFLEX LIMITED
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received 01/28/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No