GELFLEX(R) (DIMEFILCON A) CONTACT LENS

FDA Premarket Approval N17722 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceGELFLEX(R) (DIMEFILCON A) CONTACT LENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantDOW CORNING OPHTHALMICS, INC.
Date Received1979-10-30
Decision Date1980-03-14
PMAN17722
SupplementS004
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address DOW CORNING OPHTHALMICS, INC. p.o. Box 1767 midland, MI 48640

Supplemental Filings

Supplement NumberDateSupplement Type
N17722Original Filing
S005 1981-07-23
S004 1979-10-30
S003 1979-04-17
S002 1979-06-20
S001 1979-02-14

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