Cleared Traditional

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING

K964222 · Paladin Medical, Inc. · Ophthalmic
Dec 1996
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K964222 is an FDA 510(k) clearance for the ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on December 20, 1996, 59 days after receiving the submission on October 22, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K964222 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1996
Decision Date December 20, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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