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SEE3 (LOTRAFILCON A) Soft Contact Lens

by Ciba Vision Corporation

510(k) K970746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970746 Date9 May 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is a soft contact lens made of lotrafilcon A material, designed for daily wear. It is classified as a Lens, Soft Contact, Daily Wear under FDA regulation 886.5925 and falls within the ophthalmic medical specialty.

The lens is supplied as a single-use, sterile device intended for daily wear in aphakic and/or non-aphakic individuals with non-diseased eyes for the optical correction of refractive ametropia, including myopia, hyperopia, and astigmatism. It received FDA 510(k) clearance (K970746) on May 9, 1997, as substantially equivalent to a legally marketed device, and is classified as a Class II medical device.

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Questions

AI-generated answers, 26 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 SEE3 (Lotrafilcon A) Soft Contact Lens used for?

    It is used for the optical correction of refractive ametropia, including myopia, hyperopia, and astigmatism, in aphakic and/or non-aphakic individuals with non-diseased eyes.

  • How is the SEE3 contact lens supplied and is it sterile?

    The lens is supplied as a single-use, sterile device, meaning each lens is individually packaged and sterilized for one day of wear before disposal.

  • Can the SEE3 soft contact lens be reused after removal?

    No, it is designed for single-use only during daily wear and must be discarded after each use to maintain sterility and safety.

  • What material is the SEE3 contact lens made from and what is its wear schedule?

    The lens is made of lotrafilcon A material and is intended for daily wear, meaning it is worn during waking hours and removed before sleep.