FDA 510(k)

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

K-Number: K960291 · 1996-03-25

ApplicantOcu-Ease Optical Products, Inc.

Decision Date1996-03-25

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Ocu-Ease Optical Products, Inc.. It received FDA 510(k) clearance on 1996-03-25 under 510(k) number K960291. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS?

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS is a medical device that received FDA 510(k) clearance on 1996-03-25. The listed applicant is Ocu-Ease Optical Products, Inc.. The 510(k) number is K960291.

When did TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS receive FDA 510(k) clearance?

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS received FDA 510(k) clearance on 1996-03-25, under 510(k) number K960291.

Who is the listed applicant for TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS?

The FDA 510(k) record lists Ocu-Ease Optical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS?

The FDA product code for TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS is LPL.

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Other records listing Ocu-Ease Optical Products, Inc. as applicant

K023077OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)K020690OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS K011577OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S K004000OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT K003996OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR K002966OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

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Related Devices (Code: LPL)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.