ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K024177
Device Name ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
Original Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 centurion pkwy.
suite 100
jacksonville, 
FL 
32256

Original Contact james w parziale
Regulation Number 886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received 12/18/2002
Decision Date 01/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No