FDA 510(k)

BIOMEDICS UV MULTIFOCAL

K-Number: K012425 · 2001-10-12

ApplicantOcular Sciences Puerto Rico, Inc.

Decision Date2001-10-12

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

BIOMEDICS UV MULTIFOCAL is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Sciences Puerto Rico, Inc.. It received FDA 510(k) clearance on 2001-10-12 under 510(k) number K012425. 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 BIOMEDICS UV MULTIFOCAL?

BIOMEDICS UV MULTIFOCAL is a medical device that received FDA 510(k) clearance on 2001-10-12. The listed applicant is Ocular Sciences Puerto Rico, Inc.. The 510(k) number is K012425.

When did BIOMEDICS UV MULTIFOCAL receive FDA 510(k) clearance?

BIOMEDICS UV MULTIFOCAL received FDA 510(k) clearance on 2001-10-12, under 510(k) number K012425.

Who is the listed applicant for BIOMEDICS UV MULTIFOCAL?

The FDA 510(k) record lists Ocular Sciences Puerto Rico, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMEDICS UV MULTIFOCAL?

The FDA product code for BIOMEDICS UV MULTIFOCAL is LPL.

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Other records listing Ocular Sciences Puerto Rico, Inc. as applicant

K013377BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS K003136OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS K992264OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS K982947BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS K984046BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS K972303OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS

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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.