ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K122213
Device Name ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
SOFLEX LIMITED
33 golden eagle lane
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
SOFLEX LIMITED
33 golden eagle lane
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 07/25/2012
Decision Date 12/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No