Cleared Traditional

Contact Lens Case, Model: A-1, B-1

K172925 · P L Overseas Limited · Ophthalmic
Nov 2017
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K172925 is an FDA 510(k) clearance for the Contact Lens Case, Model: A-1, B-1, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by P L Overseas Limited (Cheung Sha Wan, HK). The FDA issued a Cleared decision on November 30, 2017, 66 days after receiving the submission on September 25, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K172925 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2017
Decision Date November 30, 2017
Days to Decision 66 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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