CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS


Device Classification Name

lens, contact, (disposable)

510(k) Number K080632
Device Name CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
Applicant
CLEARLAB SG PTE LTD.
806 kimball avenue
grand junction, 
CO 
81501

Applicant Contact martin dalsing
Correspondent
CLEARLAB SG PTE LTD.
806 kimball avenue
grand junction, 
CO 
81501

Correspodent Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received 03/05/2008
Decision Date 10/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No