Cleared Traditional

POREX(TM) EYE SPHERE IMPLANT

K863943 · Porex Medical · Ophthalmic
Feb 1987
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K863943 is an FDA 510(k) clearance for the POREX(TM) EYE SPHERE IMPLANT, a Implant, Eye Sphere (Class II — Special Controls, product code HPZ), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on February 27, 1987, 140 days after receiving the submission on October 10, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3320.

Submission Details

510(k) Number K863943 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 1986
Decision Date February 27, 1987
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPZ — Implant, Eye Sphere
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.3320