TORIC LITE LENS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K011256
Device Name TORIC LITE LENS
Original Applicant
SOFLEX CONTACT LENS INDUSTRIES LTD.
13 red fox ln.
littleton, 
CO 
80127

Original Contact kevin walls
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 04/24/2001
Decision Date 07/17/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No