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Sauflon Multipurpose Solution No Rub

by Sauflon Pharmaceuticals, Ltd.

510(k) K030278

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 NumberK030278 Date30 Jul 2003ClearedStatusActive

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  • Withdrawn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
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Sauflon Multipurpose Solution No Rub is an accessory for soft hydrophilic contact lenses. It is indicated for the daily cleaning, rinsing, chemical disinfection, protein removal, and storage of these lenses as recommended by an eye care practitioner.

This solution is supplied by Sauflon Pharmaceuticals, Ltd. and has received FDA 510(k) clearance. It is classified under the ophthalmic medical specialty and is regulated under 21 CFR 886.5928.

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