Cleared Traditional

VISITEC SCLERAL PLUG

K945114 · Visitec Co. · Ophthalmic

Feb 1995

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K945114 is an FDA 510(k) clearance for the VISITEC SCLERAL PLUG, a Plug, Scleral (Class II — Special Controls, product code LXP), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on February 23, 1995, 128 days after receiving the submission on October 18, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K945114 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 1994
Decision Date	February 23, 1995
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	LXP — Plug, Scleral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4155
Definition	Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.