Skip to content

Opti-Free Supraclens Daily Protein Remover

by Alcon Laboratories, Inc.

PMA P820001510(k) K990480

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization 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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK990480 Date10 May 1999ClearedStatusActive
United StatesFDA PMA PMA 1 supplement NumberP820001 Date4 Jun 1984ApprovedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
Opti-Free(R) Supra-Clens Daily Protein Remover
Trade name
Opti-Zyme(Tm) Enzymatic Cleaner
Generic name
Accessories, soft lens products
FDA applicant
Alcon Laboratories
PMA number
510(k) Number
FDA product code
LPN
Device class
Class II
Regulation
21 CFR Part 886.5928
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent
PMA supplement
S005

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.

Opti-Free Supraclens Daily Protein Remover is a soft lens product designed to remove protein deposits from contact lenses. It is manufactured by Alcon Laboratories and falls under the category of accessories for soft lens products.

This product is supplied as a single-use solution and is not indicated for MRI use. It has received FDA clearance through both 510K and PMA pathways, with the device classified as Class II. The product is intended for use in ophthalmic applications and is regulated accordingly.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

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 primary function of Opti-Free Supraclens Daily Protein Remover?

    Opti-Free Supraclens Daily Protein Remover is specifically designed to remove protein deposits from soft contact lenses. This helps maintain lens cleanliness and comfort for contact lens wearers by preventing buildup that can affect vision and lens performance.

  • What regulatory approvals does this product have?

    The product has received FDA clearance through both 510K (K974625) and PMA (P820001) pathways. It is classified as a Class II medical device under the product code LPN and is regulated for ophthalmic use. These approvals indicate that the device meets specific safety and effectiveness requirements set by the FDA.

  • Is this product suitable for use with all types of soft contact lenses?

    The product is designed for use with soft contact lenses, but specific compatibility information should be verified with the manufacturer or product instructions. While it's marketed as a protein remover for soft lenses, individual lens materials may have specific cleaning requirements that should be considered.