SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K111345
Device Name SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
Applicant
THE SEE CLEAR COMPANY, INC
16576 w. 53rd way
golden, 
CO 
80403

Applicant Contact kevin randall
Correspondent
THE SEE CLEAR COMPANY, INC
16576 w. 53rd way
golden, 
CO 
80403

Correspodent Contact kevin randall
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 05/13/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No