Atlas FDA

STERILIZED FINISHED OCUFILCON B LENSES

FDA premarket approval P820051/S009 · decided 1991-08-22

Approval details

PMA number
P820051
Supplement
S009
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
STERILIZED FINISHED OCUFILCON B LENSES
Generic name
Lenses, soft contact, daily wear
Applicant
Ocu-Ease Optical Products, Inc.
Date received
1989-09-22
Decision date
1991-08-22
Days to decision
699 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Pinole, CA

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510(k) clearances by this applicant

RecordFirmDate
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) (K023077)Ocu-Ease Optical Products, Inc.2002-12-10
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS (K020690)Ocu-Ease Optical Products, Inc.2002-04-26
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S (K011577)Ocu-Ease Optical Products, Inc.2001-06-19
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT (K004000)Ocu-Ease Optical Products, Inc.2001-02-21
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR (K003996)Ocu-Ease Optical Products, Inc.2001-02-21
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (K002966)Ocu-Ease Optical Products, Inc.2000-11-08
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (K992466)Ocu-Ease Optical Products, Inc.1999-10-04
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS (K960291)Ocu-Ease Optical Products, Inc.1996-03-25