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

Lenses, Soft Contact, Daily Wear

OCU-EASE OPTICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Ocu-flex Pediatric Aphakic (ocufilcon B) Spherical Soft Contact Lens For Daily Wear (lathe-cut).

Pre-market Notification Details

Device IDK023077
510k NumberK023077
Device Name:OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
ClassificationLenses, Soft Contact, Daily Wear
Applicant OCU-EASE OPTICAL PRODUCTS, INC. 623 GLACIER DR. Grand Junction,  CO  81503
ContactDeanna Werber
CorrespondentDeanna Werber
OCU-EASE OPTICAL PRODUCTS, INC. 623 GLACIER DR. Grand Junction,  CO  81503
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-16
Decision Date2002-12-10
Summary:summary

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