Cleared Traditional

ALCON CONTACT LENS CASE

K971618 · Alcon Laboratories · Ophthalmic
Jul 1997
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K971618 is an FDA 510(k) clearance for the ALCON CONTACT LENS CASE, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Alcon Laboratories (Fort Worth,, US). The FDA issued a Cleared decision on July 14, 1997, 73 days after receiving the submission on May 2, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K971618 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1997
Decision Date July 14, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LRX — Case, Contact Lens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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