OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K023077
Device Name OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
Original Applicant
OCU-EASE OPTICAL PRODUCTS, INC.
623 glacier dr.
grand junction, 
CO 
81503

Original Contact deanna werber
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 09/16/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No