REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K080512
Device Name REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
Applicant
METRO OPTICS OF AUSTIN, INC.
806 kimball avenue
grand junction, 
CO 
81501

Applicant Contact martin dalsing
Correspondent
METRO OPTICS OF AUSTIN, INC.
806 kimball avenue
grand junction, 
CO 
81501

Correspodent Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 02/25/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No