Cleared Special

MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K984575 · Alcon Laboratories · Ophthalmic
Jan 1999
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K984575 is an FDA 510(k) clearance for the MULTI-PURPOSE DISINFECTING SOLUTION ID 90746, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on January 14, 1999, 22 days after receiving the submission on December 23, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K984575 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1998
Decision Date January 14, 1999
Days to Decision 22 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

Similar Devices — LPN Accessories, Soft Lens Products

All 119
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · Bausch & Lomb, Incorporated · Dec 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · Chemtex USA, Inc. · Oct 2022
ABT12 multi-purpose solution
K202932 · Bausch & Lomb, Incorporated · May 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · Ote North America, LLC · May 2021
Aqua Naina Sterile Saline Solution
K193441 · Chemtex USA, Inc. · May 2020
PuriLens Plus Preservative Free Saline
K200747 · The Lifestyle Company, Inc. · May 2020