TORAY SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P840044

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceTORAY SOFT CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantToray Industries (America), Inc.
Date Received1984-09-24
Decision Date1986-01-24
Notice Date1986-03-05
PMAP840044
SupplementS
Product CodeLPM
Docket Number86M-0054
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Toray Industries (America), Inc. 1-1-1 Sonoyama otsu-shi, Shiga-ken 520 520

Supplemental Filings

Supplement NumberDateSupplement Type
P840044Original Filing
S002 1989-12-18 Normal 180 Day Track
S001 1989-07-19 Normal 180 Day Track

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