Cleared Traditional

MED-GENESIS PATIENT LASER EYE SHIELD

K934459 · Med-Genesis, Inc. · Radiology
Feb 1994
Decision
165d
Days
Class 1
Risk

About This 510(k) Submission

K934459 is an FDA 510(k) clearance for the MED-GENESIS PATIENT LASER EYE SHIELD, a Shield, Eye, Radiological (Class I — General Controls, product code IWS), submitted by Med-Genesis, Inc. (Great Neck,, US). The FDA issued a Cleared decision on February 22, 1994, 165 days after receiving the submission on September 10, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K934459 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1993
Decision Date February 22, 1994
Days to Decision 165 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWS — Shield, Eye, Radiological
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500