Cleared Traditional

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS

K945172 · Visitec Co. · Ophthalmic
Jan 1995
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K945172 is an FDA 510(k) clearance for the VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS, a Implant, Orbital, Extra-ocular (Class II — Special Controls, product code HQX), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on January 17, 1995, 88 days after receiving the submission on October 21, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number K945172 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1994
Decision Date January 17, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQX — Implant, Orbital, Extra-ocular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3340

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