Cleared Traditional

COOPER PROSTHETIC

K042435 · CooperVision, Inc. · Ophthalmic
Oct 2004
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K042435 is an FDA 510(k) clearance for the COOPER PROSTHETIC, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on October 26, 2004, 48 days after receiving the submission on September 8, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K042435 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2004
Decision Date October 26, 2004
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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