SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K033655
Device Name SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
Applicant
SOFLEX CONTACT LENS INDUSTRIES LTD.
13 red fox ln.
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
SOFLEX CONTACT LENS INDUSTRIES LTD.
13 red fox ln.
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 11/21/2003
Decision Date 07/30/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No