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O.P.R. -55 Soft Contact Lens

by N & N Contact Lens Co., Ltd.

PMA P890053

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P890053↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP890053 Date11 Sep 1990ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Lenses, soft contact, daily wear
PMA Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S002 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The O.P.R. -55 Soft Contact Lens is a daily-wear soft contact lens designed for ophthalmic use. These lenses are intended to correct refractive errors and improve visual acuity by resting directly on the cornea, providing clear and comfortable vision for extended periods.

The device is supplied as a single-use, non-sterile product, intended for professional fitting by an eye care practitioner. It is classified as a Class II medical device under FDA regulations and has received a Premarket Approval (PMA) under the designation P890053. No MRI safety information or specific storage conditions are noted in the regulatory data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the O.P.R. -55 Soft Contact Lens?

    The O.P.R. -55 Soft Contact Lens is designed for ophthalmic use to correct refractive errors and improve visual acuity by resting directly on the cornea, providing clear and comfortable vision for extended periods.

  • How is the O.P.R. -55 Soft Contact Lens supplied?

    The device is supplied as a single-use, non-sterile product intended for professional fitting by an eye care practitioner.

  • What is the regulatory classification of the O.P.R. -55 Soft Contact Lens?

    The O.P.R. -55 Soft Contact Lens is classified as a Class II medical device under FDA regulations and has received a Premarket Approval (PMA) under the designation P890053.

  • Is the O.P.R. -55 Soft Contact Lens reusable or single-use?

    The O.P.R. -55 Soft Contact Lens is supplied as a single-use product and should not be reused according to its regulatory data.

  • Are there specific storage conditions for the O.P.R. -55 Soft Contact Lens?

    No specific storage conditions are noted in the regulatory data for the O.P.R. -55 Soft Contact Lens.